UPDATE - January 13, 2023: The FDA is clarifying if the faster than expected flow rates are not recognized and adjusted to deliver the appropriate dose, it may result in serious adverse health consequences.
The FDA has identified this as a Class I recall, the most serious type of recall.
- Product Name: Intera 3000 Hepatic Artery Infusion Pump
- Serial Numbers: See Recall Database entry
- Devices Recalled in the U.S.: 50
- Dates distributed: August 12, 2021 to May 17, 2022
- Date Initiated by Firm: July 10, 2022
The Intera 3000 Hepatic Artery Infusion Pump is used to continuously deliver medicine through the hepatic artery, which supplies blood and oxygen to the liver and several other organs. The pump is implanted into adult patients and delivers chemotherapy medications to treat liver tumors. People with the Intera 3000 Hepatic Artery Infusion Pump are able to get back to daily activities and return to the treating physician for pump refills every two weeks.
Reason for Recall
Intera Oncology is recalling certain units of Intera 3000 Hepatic Artery Infusion Pumps (50 products in the U.S.) after receiving reports from clinicians that the affected pumps were delivering medications (flow rate) faster than expected.
If the pump delivers infusions at faster than expected flow rates, the patient may receive more medication than planned, which could result in increased risk of liver toxicity if the fast flow is not recognized and adjusted to deliver the appropriate dose. If too much drug is administered, it may result in serious adverse health consequences.
There have been three incidents reported related to this issue, with no injuries or deaths.
Who May Be Affected
- Healthcare personnel who implant the Intera 3000 Hepatic Artery Infusion Pump or who manage the care of patients with an Intera 3000 Hepatic Artery Infusion Pump.
- People who receive infused medications using the Intera 3000 Hepatic Artery Infusion Pump.
What to Do
On July 10, 2022, Intera Oncology sent a letter, emailed, or called customers and requested the following actions:
- Continue to monitor flow rate per standard refill procedure.
- Continue to monitor for liver toxicity to adjust dosing as per standard protocols.
- Consider pump replacement if altered flow rate of the pump can't be adequately managed by dosing adjustments of the infusate when hepatic artery infusion therapy needs to continue.
- Consider bringing patient in for medication refill and to verify the flow rate sooner than every two weeks if the pump appears to be flowing more than 15% outside of labeled specification.
- Flush the bolus pathway with low dose heparinized saline (100 IU/ml) using the special bolus needle (per the Instructions for Use) if the pump is empty at the time of refill.
- The hepatic artery infusion therapy care team should decide whether or not to inform the patient about the possibility of alterations in flow.
- Notify any new clinicians about the possibility of altered flow in the future if a patient's care is transferred to a new treating facility.
Customers with questions or concerns about this recall should contact Intera Oncology at (800) 660-2660 or firstname.lastname@example.org with questions.
How do I report a problem?
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.