BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16074887 · Received December 29, 2022

    Report

    Report Number
    2249723-2022-03509
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO EVALUATE THE IABP UNIT. THE STM FOUND INTRUSION INTO THE SAFETY DISK AND DRIPPING ON THE PNEUMATIC INTERFACE PCB. THE PNEUMATIC MODULE ASSEMBLY (0997-00-1178) AND PNEUMATIC INTERFACE PCB (0670-00-1167) WERE REPLACED. THE STM COMPLETED 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 ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED BLOOD BACK INTO PUMP. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2410549 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 69 YR Male