The FDA today warned that the recall of an infusion pump from Intera Oncology is Class I, the most serious kind.
Intera recalled the Intera 3000 hepatic artery infusion pump after receiving reports from clinicians that the pumps were delivering medications (flow rate) faster than expected. If the pump delivers infusions at faster than expected flow rates, the patient may receive too much medication at one time, resulting in life-threatening hematologic (myelosuppression) toxicity, neurotoxicity or death.
Additionally, if the flow rate is too fast, the patient may run out of medication before a pump refill occurs, which may allow their disease to progress or lead to death.
According to the FDA notice, the company initiated the recall on July 10, 2022. It affects 440 devices that were distributed in the U.S. between Aug. 12, 2021, and May 17, 2022. To date, Intera has received reports of three incidents related to the issue, with no reports of injuries or death.
The Intera 3000 hepatic artery infusion pump continuously delivers medicine through the hepatic artery, which supplies blood and oxygen to the liver and several other organs. The pump is implanted in adult patients and delivers chemotherapy medications that treat liver tumors, with users capable of returning to daily activities with pump refills performed at the hospital every two weeks.
Intera’s recall notice told customers to monitor flow rates per standard refill procedure and monitor for liver toxicity to adjust dosing as per standard protocols.
Users should consider pump replacement if the 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, Intera instructed. They should also consider verifying their flow rate sooner than every two weeks if the pump appears to be flowing more than 15% outside of the labeled specification.
Customers may also look to flush the bolus pathway with low dose heparinized saline (100 IU/ml) using the special bolus needle if the pump is empty at the time of refill, while their care team should decide whether to inform the patient of the possibility of alterations in flow.