BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20571269 · Received October 30, 2024

    Report

    Report Number
    2249723-2024-0004460
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 9, 2024
    Report Date
    January 20, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND WAS ABLE TO VERIFY THE REPORTED MALFUNCTION. FSE INSPECTED THE UNIT TO SEE WHICH PARTS WERE INVOLVED IN THE BLOOD INGRESS AND DETERMINED THE PARTS WHICH NEEDED REPLACEMENT. FSE REPLACED THE PNEUMATIC MODULE ASSEMBLY (0997-00-1178), THE PRESSURE VACUUM RESERVOIR (0202-00-0170-03), AND THE DRIVE MANIFOLD ASSEMBLY (0104-00-0031). THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BALLOON RUPTURE, BLOOD BACKED UP INTO HELIUM DISK. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929682 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown