BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000 HEPATIC ARTERY INFUSION PUMP OR PREP KIT

    MDR report key: 21549516 · Received March 7, 2025

    Report

    Report Number
    3015537318-2025-00013
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 7, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    PTI
    UDI-DI
    00850014110130
    PMA / PMN Number
    K211121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD, DHR-000014, WAS REVIEWED. THE OR PREP KIT WAS MANUFACTURED ON OCTOBER 12, 2023. THERE WERE NO NONCONFORMANCES PERTAINING TO THIS LOT NUMBER. THE OR PREP KIT MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. THE COMPLAINT WAS ABOUT THE SPECIAL BOLUS NEEDLE FAILING TO BOLUS IN THE PUMP. THE CUSTOMER STATED THEY USED THE BACKUP BOLUS NEEDLE AND HAD NO PROBLEM. THE NEEDLE WAS RECEIVED ON FEBRUARY 18, 2025. ON FEBRUARY 26, 2025, THE INTERA QUALITY TEAM EVALUATED THE RETURNED DEVICE. THE DEVICE WAS REMOVED FROM PACKAGING AND PLACED IN A 20% SOLUTION OF BLEACH TO DISINFECT. A 10ML SYRINGE WAS FILLED WITH BLEACH SOLUTION AND CONNECTED TO A TUBING SET. DEVICE WAS IDENTIFIED AS A REFILL NEEDLE, LOT 23J260CT, CONNECTED TO A TUBING SET. NO DEVICE DEFECTS WERE DETECTED, TUBING SET FLUSHED AS EXPECTED. THE COMPLAINT INVESTIGATOR WAS ABLE TO INJECT THROUGH THE TUBING SET WITH NO PROBLEM. ALL INDICATIONS LEAD TO THAT THE PHYSICIAN USED THE INCORRECT NEEDLE INSTEAD OF THE SPECIAL BOLUS NEEDLE, THEREFORE, WE ATTRIBUTE THIS INCIDENT TO USE ERROR.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT OF AN OR PREP KIT NEEDLE (SBN) THAT WOULDN'T FLUSH THE CATHETER. THE PUMP WAS PREPPED WELL AND WAS BEING SUPPORTED THE CASE REMOTELY BY AN INTERA ONCOLOGY CLINICAL ACCOUNT SPECIALISTS (CAS). THE PHYSICIAN IMPLANTED THE PUMP AND CATHETER, NEEDLE WAS FULLY DEPRESSED AND UNCLAMPED, BUT IT WOULD NOT FLUSH. THE CAS REPRESENTATIVE ASKED THE PHYSICIAN TO REMOVE THE NEEDLE, PRIME, RE-ACCESS, HOWEVER IT STILL WOULD NOT FLUSH. ANOTHER INTERA ONCOLOGY EMPLOYEE WALKED THROUGH THE IMPLANT WITH THE PHYSICIAN AND RELATED THE SAME INFORMATION PROVIDED BY THE CAS REPRESENTATIVE. THE PHYSICIAN WAS TOLD TO USE THE BACKUP OR PREP KIT NEEDLE (SBN), TO PRIME AND REACCESS. THE OUTCOME WAS THAT THE PHYSICIAN WAS ABLE TO FLUSH THE CATHETER WITH THE BACKUP OR PREP KIT NEEDLE. INTERA ONCOLOGY ASKED THE PHYSICIAN TO SALVAGE THE NEEDLE AND RETURNED TO INTERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098799 INTERA 3000 HEPATIC ARTERY INFUSION PUMP OR PREP KIT OR PREP KIT PTI INTERA ONCOLOGY, INC AP-07004 23K108CT 00850014110130

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male