BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16065421 · Received December 28, 2022

    Report

    Report Number
    2249723-2022-03467
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    September 11, 2020
    Report Date
    December 21, 2022
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO INVESTIGATE. THE STM EVALUATED THE IABP UNIT AND TRACED BLOOD FROM THE PNEUMATIC MODULE ASSEMBLY (PIM) TO THE SCROLL COMPRESSOR. THE STM REMOVED THE CONTAMINATED PARTS AND REPAIRS ARE ON HOLD UNTIL THE REPAIR PURCHASE ORDER IS APPROVED. SUBSEQUENTLY, THE STM RETURNED TO THE CUSTOMER'S SITE AT A LATER DATE AND PERFORMED THE REPAIRS ON THE IABP UNIT. THE STM REPLACED THE PNEUMATIC MODULE ASSEMBLY (0997-00-1178), THE PIM TO BACKPLANE CABLE ASSEMBLY (0012-00-1640), TIDAL VOLUME DISK (0202-00-0142), HELIUM RESERVOIR ASSEMBLY (0997-00-0565), PRESSURE-VACUUM RESERVOIR (0202-00-0170-03), MUFFLER TO RESERVOIR FITTING (0103-00-0626), O-RING (0354-00-0175), RELATED FILTERS (0103-00-0499 & 0103-00-0709), IN-LINE FEMALE PNEUMATIC FITTING (0103-00-0657-01), TUBING (0008-00-0377), AND RELATED SCREW KITS. THE STM THEN PERFORMED PREVENTATIVE MAINTENANCE (PM) INCLUDING ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD BLOOD BACK INTO THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453526 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown