On August 29, 2022, the U.S. Food and Drug Administration (FDA) reported Intera Oncology’s recall of the Intera 3000 hepatic artery infusion pump because of reports that the devices were delivering medications faster than expected. FDA identified it as a class I recall, the most serious type of recall, where use of the device may cause serious injuries or death.
Intera Oncology received three reports about the delivery defect, none of which were associated with injuries or death. The recall affects 440 devices distributed from August 12, 2021–May 17, 2022. For a list of recalled product codes, see FDA’s medical device database.
FDA explained that if the pump delivers medication faster than expected, a patient can receive an excessive amount, resulting in life-threatening hematologic toxicity (i.e., myelosuppression), neurotoxicity, or death. Additionally, the medication can run out before the pump refills, which may lead to disease progression or death.
Intera Oncology sent a notice to customers in July 2022 and recommended the following actions:
- Monitor flow rate per standard refill procedure.
- Monitor for liver toxicity to adjust dosing.
- Consider replacing the pump if the altered flow rate can’t be adequately managed with infuscate dosing adjustments.
- Consider bringing the patient in for medication refills and to verify the flow rate sooner than every two weeks if the pump is flowing more than 15% outside of specification.
- Flush the bolus pathway with a low-dose heparinized saline (100 IU/ml) using the special bolus needle if the pump is empty at time of refill.
- Notify new clinicians about the possibility of altered flow in the future.
Intera Oncology also suggested that the hepatic artery infusion therapy care team decide whether to inform patients about the possibility of flow alterations.
Customers with questions about the recall can contact Intera Oncology at 800-660-2660 or firstname.lastname@example.org.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.