FDA MedWatch - Intera 3000 Hepatic Artery Infusion Pump by Intera Oncology

Class I Recall - Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC:  Intera 3000 Hepatic Artery Infusion Pump by Intera Oncology: Class I Recall - Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery AUDIENCE: Patient, Health Professional, Risk Manager, Oncology ISSUE: Intera Oncology is recalling 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. There have been three incidents reported related to this issue, with no injuries or deaths. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Intera 3000 Hepatic Artery Infusion Pump is used to continuously deliver medicine through an artery that supplies blood and oxygen to the liver and several other organs (hepatic artery). The pump is implanted into adult patients and delivers chemotherapy medications to treat liver tumors. RECOMMENDATIONS: 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. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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