INTERA 3000 HEPATIC ARTERY INFUSION PUMP OR PREP KIT

Description of Event or Problem

ON (B)(6) 2025, A NURSE ATTEMPTED TO FILL THE INTERA 3000 HAI PUMP WITH HEPARIN USING THE INTERA 3000 REFILL KIT. THE NURSE NOTICED A CRACK AND LEAKAGE IN THE TUBING NEAREST TO THE SYRINGE. WHEN ASKED WHERE SPECIFICALLY THE CRACK AND LEAKAGE OCCURRED, THE NURSE MENTIONED THAT IT WAS IN THE LUER LOCK CONNECTOR AREA. THE NURSE REPLACED THE TUBING BY USING ANOTHER KIT. NO HARM TO THE PATIENT WAS REPORTED. THE CLINIC DISCARDED THE SAMPLE.

Additional Manufacturer Narrative

A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INTERA ONCOLOGY ASKED THE NURSE PRACTITIONER FOR THE REQUIRED PATIENT INFORMATION AND OUR REQUEST WAS REJECTED DUE TO PRIVACY REASONS. AS PREVIOUSLY MENTIONED, THE PRODUCT WAS DISCARDED BY THE CLINIC. THEREFORE, THE ROOT CAUSE IS INCONCLUSIVE.