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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Medibo N.V. 10/2/09

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993

 

OCT 2 2009

 

Jos Bollen
Managing Director
MEDIBO N.V.
Heikant 5
3930 Hamont-Achel, Belgium

 

WARNING LETTER

Dear Mr. Bollen:

During an inspection of your firm located in Hamont-Achel, Belgium, on January 19 through 22, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures patient lifts, and slings which are components of a device. 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 are intended to affect the structure or 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received responses from you dated February 25, 2009, May 7, 2009, June 9, 2009, June 23, 2009 and June 30, 2009, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, which was issued to you. Your responses presented design verification and validation of slings used with the lifts. Your battery operated lifts are Class I devices. Design controls for Class I devices are not enforced under the Act. Observations one, two and three of the FDA 483, which pertain to design controls, are not noted in this Warning Letter. However, your responses do not adequately address Medical Device Reporting, which is the emphasis of this Warning Letter.

We address the FDA 483 Observations below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to adequately ensure that any complaint that represents an event which must be reported to FDA under Part 803 shall be promptly reviewed, evaluated, and investigated to determine whether the device failed to meet specifications, as required by 21 CFR 820.198(d)(1).

For example: the following complaints did not include a determination of whether the device failed to meet specifications:

a. Complaint 2008-1170; AC08-0402-, the KA1210 sling was reported to have many frays and was extremely worn. The incident was stated as user error. This sling was the subject of a recall in 2007.

b. Complaint 2007-373; AC07-0663, the Maxilift device was the subject of a recall in 2000 due to a roll pin shear (212000-06). The incident resulted in a patient death.

c. Complaint 2008-852; AC08-0315, the Maxilift device was the subject of a recall in 2000 due to a roll pin shear (212000-06).

Your response to this observation appears to be adequate.

2. Failure to maintain the complaint files, as required by 21 CFR 820.198(a).

For example: sling complaint (MDR 9617021-2008-00015 dated July 23, 2007) was missing from the file.

Your response to this observation appears to be adequate.

Our inspection also revealed that your patient lift 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 (MDR) regulation. Significant deviations include, but are not limited to, the following:

1. Failure to conduct a complete investigation of each event to determine the cause of the event, as required by 21 CFR 803.50(h)(3).

For example: In complaints (#2008-1170) (MDR 9617021-2008-00030); (#2008-852), (MDR 9617021-2008-00024); and (#2007-373) (MDR 9617021-2007-0055) your firm failed to conduct an investigation of each event to determine the cause of the event, including whether the device met specifications. One of the events resulted in death and two resulted in a serious injury to the patient.

Complaint number 2008-1170 (MDR 9617021 -2008-00030) involves a 16 year old SARA Lift produced in 1992 from Arjo's UK production facility. "The MDR lists the event date as July 18, 2008, and the FDA received the event on August 8, 2008. While being lowered into an easy chair from a wheelchair, the resident's arms came up over head, hyper-extending the shoulders. "The resident fractured their left shoulder. The complaint file indicates that the sling was 14 years old and was not returned for actual specification testing. Your firm determined that the patient appeared to have pathology, such as brittle bone disease, which made the resident unsuitable for transfer and concluded that user contributed to the event. Your firm also indicates that the expected lifetime of the sling is 2 years, but the "operational life" of the sling/stretcher is dependent upon actual use conditions. However, FDA is not sure what Medibo's labeled life expectancy is for the sling/stretcher or whether the "operational life" is equivalent to less than 2 years (with excessive use) or greater than 14 years (with very minimal use). For MDR purposes, your firm has not adequately established an end-of-life cycle for this product that will allow us to agree that the event is related to a patient condition or user error rather than to a failure of the device.

Complaint number 2008-852 (MDR 9617021-2008-00024) involves a Maxi Lift device. The MDR lists the event date as May 22, 2008, and the FDA received the event on June 6, 2008. A resident was being lowered to the floor during a transfer when one of the clips on the sling broke. The sling used during the incident was discarded by housekeeping to "get it out of circulation". The complaint file indicates that your firm could not establish if the sling involved was manufactured by Arjo or Medibo. Information in the file also indicates that your firm could not investigate the broken part and therefore could not come to a definitive conclusion of the root cause of the incident. However, the complaint file information indicates that your firm was in receipt of previous complaints involving Arjo slings where the clip is indicated as being deformed or giving way during intended use. The device was also the subject of a prior 1999 recall in which a molding defect contributed to clip breakage. Your firm should have reviewed these other records as part of your investigation to determine if the clip breakage could have been due to a manufacturing defect.

Complaint number 2007-373 (MDR 9617021-2007-00055) involves a Maxi Lift device. According to the MDR, the event occurred on November 5, 2007, and FDA received the MDR on November 26, 2007. While a resident was being moved from the bed and lowered to the floor the strap holding the clips of the sling to the positioning arm tore. The resident complained of a hurt knee and was transferred to the hospital where they later died. The sling was not received for investigation, but pictures were provided. Information from the file states that both the lift and sling were found in a state that no longer allows safe functioning or use. Your firm determined that the root cause of the incident was due to use error. However, other information in the complaint report states that the direct link between the reported incident and the patient death is unclear to your firm from the information received.

Your firm also indicates that the expected lifetime of the sling is 2 years, but the "operational life" of the sling/stretcher is dependent upon actual use conditions. FDA is not sure what Medibo's labeled life expectancy is for the sling/stretcher or whether the "operational life" could be equivalent to less than 2 years (with excessive use) or greater than 2 years (with very minimal use). For MDR purposes, your firm has not adequately established an end-of-life cycle for this product that will allow us to agree that the event is related to user error rather than a failure of the device.

Your firm's response to Observation 4 of the form FDA 483 was to update procedures for complaint handling and failure investigations, and create a new workflow of forwarding MDDFs to the lift manufacturers.

We have reviewed your response to Observation 4 and have concluded that it is inadequate. Your response docs not describe how your firm will incorporate the updates to insure that a complete investigation of MDR events is conducted.

2. Failure to submit an MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and 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: Complaint number 2007-303; AC07-0423 (MDR was not filed) involves a SARA 3000. The complaint report indicates that a strap broke while a resident was being lifted. The sling is identified as an Active Cord Wipe-down Sling and was reported to be in place when the chin strap sheared off. The facility has two SARA 3000 lifts, both in good condition. Your firm determined that in both normal use and foreseeable misuse the chest strap is not likely to disengage from the sling when used according to the manufacturer's instructions. According to the complaint file your firm is of the opinion that the information received does not allow for a root cause to be established with reasonable certainty. However, the sling for the device involved in this event was the subject of a 2007 recall.

The information in the complaint file indicates that your firm was in possession of information that reasonably suggests that one of your marketed devices may have malfunctioned and would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. Your firm failed to submit this event to the FDA within the 30-day timeframe, required by 21 CFR 803.50(a)(2).

Complaint number 2007-301; AC07-0381 (MDR was not filed) involves A SARA 3000. While the resident was in a standing position, the buckle hook or chest strap came undone, the sling ripped at both sides, and the patient fell. No injuries were reported. According to the complaint file, a design change was made to the stitching on the sling where the single seam design was changed to a double scam design at the end of 2005. It is noted that the design change was made to ensure that the scams would not become undone even under heavy use. The sling involved in this complaint is of the single thread design.

According to the complaint file the pictures and description of the events received by your firm finds the damage shown on the sling is not consistent with the description of events and did not establish a root cause for this event. However, the sling for this device was the subject of a 2007 recall.

The information in the complaint file indicates that your firm was in possession of information that reasonably suggests that one of your marketed devices may have malfunctioned and would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. Your firm failed to submit this event to the FDA within the 30-day timeframe required by 21 CFR 803.50(a)(2).

Your response to Observation 5 is to log weekly the time from registration of an adverse event received by Medibo to reporting the adverse event to Arjo Inc., or another lift manufacturer.

Observation 5 addresses your firm's failure to submit an MDR to FDA within the regulatory timeframe. We have reviewed your response and have concluded that it is inadequate because your fum does not state how you will meet the 30 day timeframe for submitting MDRs.

3. Failure to maintain copies of all MDR forms, as required by 21 CFR 803.18 (b)(1)(ii). 

For example: there is no record of MDR 9617021-2008-00015 in your firm's complaint files.

Your response to form FDA 483 Observation 6 is to create a list of all MDRs referred to the complaints. Your response consists of a QA Product Failure report for complaint #2007-163. We have reviewed your response and concluded that it is inadequate because your firm does not state how it will maintain complete complaint files based on the requirements of CPR 803.18.

Your firm also submitted a revised "Medical Device Reporting Procedure" (Rev. 3) in response to this observation. We have reviewed your MDR procedure and determined that it is not acceptable in that the procedure is written for Arjo, Inc. and only discusses responsibilities for Arjo Inc. (importer) and not those of Medibo as the device manufacturer.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections arc completed. Section 801(a) of the Act (21 U.S.C. § 381(a)). Also, U.S. federal agencies are advised of the issuance of all 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 deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted tu1til the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.

Your response should be sent to: Betty W. Collins, Director, Division of Enforcement A, Office of Compliance, CDRH, Building 66, Room 3516, 10903 New Hampshire Avenue, Silver Spring.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.

Your response should be sent to: Betty W. Collins, Director, Division of Enforcement A, Office of Compliance, CDRH, Building 66, Room 3516, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002. If you have any questions about the content of this letter please contact: Valerie A. Flournoy, Branch Chief, General Hospital Devices Branch, 301-796-5770 or FAX 301-847-8137.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the lnspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

 

Sincerely yours,

/s/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

 

(b)(4)