Inspections, Compliance, Enforcement, and Criminal Investigations

Datascope Corporation 9/11/18

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Medical Device and Radiological Health
Operations (Division 1)
One Montvale Avenue
Stoneham, MA 02180

 

WARNING LETTER
CMS # 562738
 
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
September 11, 2018
 
Mr. Frank Bernardo
Vice President of Operations
Datascope Corporation
15 Law Drive
Fairfield, NJ 07004
 
Dear Mr. Bernardo:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 15 Law Drive, Fairfield, NJ, from March 19, 2018 through June 11, 2018. During the inspection, FDA investigators determined that your firm is a device manufacturer of Sensation Plus 8Fr Intra- aortic balloon catheter, Mega 7.5 Fr Intra-aortic balloon catheter, Sensation Plus 7.5 Fr Intra-aortic balloon catheter, and cardiopulmonary bypass tubing packs. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
 
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response, dated July 2, 2018, from Philip Freed, Managing Director for Getinge Group Americas, concerning our investigators observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on June 11, 2018. We received an additional response from your firm dated August 30, 2018 and will evaluate this response along with any other written material provided in response to the violations cited in this letter. We address your response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1.    Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm performed a supplier assessment from (b)(4) for Circulatory Technology and approved  (“(b)(4)”) the use of  your supplier’s Better Bladder with your Custom Tubing Sets on (b)(4), which are used as part of an extracorporeal membrane oxygenation cardiopulmonary bypass circuits. However, complaint 148267 was submitted as a MDR on October 17, 2017 for an event that occurred with the Better Bladder on September 26, 2017 where the product failed to meet specifications (“product in the field was released as nonconforming to established specifications”). The Better Bladder malfunctioned due to the seal between the small tubing with the Luer fitting (pigtail) separating from the housing, allowing air to enter the housing and collapsing the balloon. The collapse of the balloon can increase resistance to flow in the venous line and causes a drop in ECMO circuit blood flow. Your firm’s failure to implement adequate purchasing controls has resulted in the expansion of the Better Bladder recall by your supplier, during the month of March of 2018, to include more lots of product after you received complaints related to device failure. For example, the following complaints were identified by your firm relating to failure of the Better Bladder device:
 
A)    Complaint 159241(Better Bladder leak event occurred on February 1, 2018; MDR for life threatening adverse event was filed on February 27, 2018) for Rotoflow Custom Pack documents a small leak on the pressure line connection of the Better Bladder. This resulted in the patient having to go back on full Cardiopulmonary Support with a heart lung machine while they prepared another circuit. The second circuit also leaked (Better Bladder) in the same location. They were able to seal the leak and use the second circuit. This resulted in the patient needing additional blood product.
 
B)    Complaint 159242 (Better Bladder leak event occurred on January 25, 2018; MDR for product problem event was filed on February 27, 2018) for Rotoflow Custom Pack documents while priming the circuit, a small leak was detected coming from the pressure line on the Better Bladder. The device was cut out and replaced with one from the hospital inventory.
 
C)    Complaint 160656 (Better Bladder leaked during use on February 22, 2018; MDR for product malfunction was filed on March 15, 2018) for BO-TOP 20705 Custom Pack documents a device malfunction for the Better Bladder component due to leaking during use. The component was changed and nothing was reported concerning the condition of the patient.
 
D)    Complaint 159545 (Better Bladder leak event occurred on February 6, 2018; MDR for product malfunction was filed on March 1, 2018) for Custom ECLS Pack BO-TOP 20705 leaked during Extra Corporeal Life Support process where the Better Bladder component was removed from the circuit and was returned directly to the original equipment manufacturer (supplier of component device) by the facility.
 
Your response is not adequate and does not address the above violation. Specifically, your firm concluded that the root cause is procedural concerning supplier management and assessment process, as such no product is impacted and therefore no immediate corrections (no preventive action is required) or containment is required. However, your firm’s failure to establish adequate purchasing controls has resulted in a sub-recall of  your finished device (Rotoflow Custom Pack with a Better Bladder component on the circuit) due to a malfunction (small leak on the pressure line connection of the Better Bladder) that has resulted in a patient having to go back on full Cardiopulmonary Support with a heart lung machine while your customer prepared another circuit. This malfunction of your product resulted in the patient needing more blood product. Your response also does not address your failure to select suppliers on the basis of their ability to meet specified requirements (your product in the field was released as nonconforming to your established specifications), including quality requirements.
 
Furthermore, CAPA (CRF-FAI-2018-030, signed on June 8, 2018) included as an attachment to your July 2, 2018 response states that “Since the end users of the above mentioned products received the appropriate field action notifications, there is no additional risk to the patient”. Please understand that just because your device was recalled does not assure your supplier has implemented the appropriate corrective actions to their quality system.
 
2.    Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Specifically, on March 22, 2013, a change was made to your Sensation Plus kits (0684-00-0574) concerning the (b)(4) to be used to coat the sheath seal to address the complaints for insertion difficulty (customer misuse). This change resulted in the migration of (b)(4) onto the package (container closure system for the finished device) from the device.  Your firm failed to validate or where appropriate verify that the design change or the change made to the manufacturing process did not affect (migration of (b)(4) onto the package) the safety or effectiveness of the finished device.  For example:
 
A)    On August 8, 2017 (CRF-FAI-2017-036), nonconforming products (Linear, Sensation, Sensation Plus 7.5Fr IABs) were shipped to your customers (June, July, and August 2017) where “a total of (b)(4) complaints in which (b)(4) IAB kits and (b)(4) insertion kits were reported due to foreign matter on the pouch.”  “Each of the complaints are MDR reportable”. “The reported foreign matter in the pouch is (b)(4) which has migrated from the coated membrane or reinforced sheath.” “The most likely cause of (b)(4) migration is that (b)(4) is a lubricant and as such is prone to migration”.  “Because (b)(4) is a component of the finished device, the returned product does not meet specifications, but remains safe and effective to use”. However, “the risk associated with (b)(4) migration, a dissatisfied user, difficulty handling the part and/or a delay in therapy” were documented (CRF-FAI- 2017-036). No testing was performed to show devices with migrated (b)(4) onto the packaging would not affect the performance of your finished devices.
 
The adequacy of your response cannot be determined at this time. Your response states that you have initiated CAPA Request Form (CRF) FAI-2018-041.  It further states that “a CAPA will be assigned to review the manufacturing procedure, review the product specification for clarity on the nature of (b)(4) migration, and to further confirm that (b)(4) migration has no effect on performance an internal evaluation of the returned units will be performed”. Please provide an update on the status of this corrective action.
 
Our inspection also revealed that your firm’s devices are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to:
 
1.    Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
 
For example, the information included for Complaint 93954 reasonably suggests that your firm’s Intra- Aortic Balloon catheter and accessories may have caused or contributed to a patient death as a result of device malfunction. Your firm became aware of the referenced event on June 11, 2015. The corresponding MDR 2248146-2015-01009 was received by FDA on September 10, 2015, which is beyond the 30-calendar day timeframe.
 
The adequacy of your response cannot be determined at this time. Your response indicated that the root cause for your firm’s late MDRs is that the current process does not adequately provide an effective escalation pathway to prevent late MDR reporting. As a result, CAPA FAI-2018-007 has been opened to investigate and determine corrective actions for late MDR reports. However, your firm did not provide evidence of those planned corrections and corrective actions with the response to FDA. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy.
 
2.    Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
 
For example, the information included for Complaint 151851 describes that your firm’s Intra-Aortic Balloon catheter and accessories malfunctioned during use. The referenced malfunction (i.e. failed to inflate) has in the past caused or contributed to a patient death, therefore establishing precedence that the malfunction would be likely to cause or contribute to a death or serious injury if it were to recur.
 
There is no information included for the complaint that justifies that the malfunction referenced for Complaint 151851 would not be likely to cause or contribute to a death or serious injury. Therefore, the information included for the referenced complaint represents a reportable malfunction. Your firm became aware of the referenced event on September 19, 2017. The corresponding MDR 2248146-2017- 00636 was received by FDA on November 13, 2017, which is beyond the 30-calendar day timeframe.
 
The adequacy of your response cannot be determined at this time. Your response indicated that the root cause for your firm’s late MDRs is that the current process does not adequately provide an effective escalation pathway to prevent late MDR reporting. As a result, CAPA FAI-2018-007 has been opened to investigate and determine corrective actions for late MDR reports. However, your firm did not provide evidence of those planned corrections and corrective actions with the response to FDA. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy.
 
3.    Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “Medical Device Report and Vigilance Management (MDR/MDV)”, Document No. 07-032, Revision E, undated, the following deficiencies were noted:
 
(1)   There is no evidence that your firm’s MDR procedure have been implemented. For example, there is no effective date for the procedure.
 
(2)   The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example:
 
a.  There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
 
b.  The flowchart in your firm’s procedure does not reference a process for investigating events identified as MDRs to ensure that MDRs are submitted to FDA within the required reporting timeframes, as required under 21 CFR 803.17(a)(1).
 
(3)   The procedure does not describe how it will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b) including:
 
a.  Documentation of adverse event related information maintained as MDR event files.
 
b.  Information that was evaluated to determine if an event was reportable.
 
c.    Documentation of the deliberations and decision-making processes used to determine if a device- related death, serious injury, or malfunction was or was not reportable.
 
d.   Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
Your response did not address this deficiency. Your firm’s response included the same MDR procedure as was collected by the FDA investigator during the inspection.
 
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated  by  the  FDA  without  further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
 
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
If you have questions regarding any issues in this letter, please contact Compliance Officer, Robert J Maffei at 973-331-4906 or at Robert.Maffei@fda.hhs.gov. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, at Gina.Brackett@fda.hhs.gov.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
 
 
Sincerely,
/S/ 
Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Division

Page Last Updated: 09/27/2018
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