BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000 HEPATIC ARTERY INFUSION PUMP

    MDR report key: 14962237 · Received July 8, 2022

    Report

    Report Number
    3015537318-2022-00011
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    May 16, 2022
    Report Date
    August 21, 2022
    Manufacturer
    INTERA ONCOLOGY
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Removal / Correction Number
    Z-1255-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, DEVICE EVALUATION IS NOT YET COMPLETED. THE DEVICE IS ANTICIPATED TO BE RECEIVED AND THEN EVALUATED. AT COMPLETION OF THE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    DEVICE WAS EVALUATED AND CONFIRMED TO BE FLOWING ABOVE SPECIFICATION. Z NUMBER IS ADDED TO THIS MDR REPORT.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED INFORMATION FROM A HEALTH CARE PROVIDER ALLEGING A FASTER THAN EXPECTED FLOWING INTERA 3000 HEPATIC ARTERY INFUSION PUMP. THE LABELED INTRA-ARTERIAL FLOW RATE OF AS MANUFACTURED IS 1.2 ML/DAY. IMPLANT DATE WAS (B)(6) 2022. THE CLINICIAN REPORTED THAT THE PUMP WAS REFILLED ON THE FOLLOWING DATES: (B)(6) 2022 WITH 11ML RESIDUAL OVER 12 DAYS (1.583 ML/DAY), (B)(6) 2022 WITH 11.5 ML RESIDUAL OVER 14 DAYS (1.3 ML/DAY), (B)(6) 2022 8 ML RESIDUAL OVER 14 DAYS (1.57 ML/DAY), (B)(6) 2022 0.25 ML RESIDUAL OVER 14 DAYS (2.13 ML/DAY), (B)(6) 2022 0 ML RESIDUAL OVER 15 DAYS (APPROX. 2 ML/DAY), (B)(6) 2022 9.5 ML RESIDUAL OVER 10 DAYS (APPROX. 2.05 ML/DAY), (B)(6) 2022 24 ML RESIDUAL OVER 3 DAYS (APPROX. 2 ML/DAY). IT WAS LATER REPORTED VERBALLY THAT THE PATIENT RETURNED ON (B)(6) 2022 WITH 27.5 ML RESIDUAL OVER 10 DAYS WAS RETURNED (APPROX. 0.25 ML/DAY). THE CLINICIAN CONFIRMED THAT THE PATIENT DID NOT HAVE ANY OTHER FACTORS THAT WOULD INCREASE THE FLOW (NO TRAVEL, MOUNTAINS, HEATING PADS, HOT TUBS, BATHS, MRIS, ETC). THE CLINICIAN MADE THE DECISION TO EXPLANT THE PUMP, WHICH WAS ULTIMATELY EXPLANTED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086682 INTERA 3000 HEPATIC ARTERY INFUSION PUMP HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY AP03000H 28475 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention