BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20289733 · Received September 24, 2024

    Report

    Report Number
    2249723-2024-0003891
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 31, 2024
    Report Date
    October 10, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE FOUND THAT THE IAB CATHETER RUPTURED AND BLOOD INGRESS TO THE UNIT. THE FSE FOUND BLOOD IN THE PIM AND SAFETY DISK. THE FSE REPLACED THE PIM, AND THE 30PSI TRANSDUCERS WERE RECALIBRATED. THE UNIT PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD BLOOD IN HELIUM TUBING AND POSSIBLY IN PUMP. THE NURSE CALLED TO REPORT A BALLOON HAD PERFORATED AND THERE WAS POSSIBLE BLOOD BACK TO THE PUMP. THIS WAS AN AXILLARY INSERTED IAB CATHETER. THE NURSE STATED THERE WAS NO HARM TO PATIENT DUE TO THIS ISSUE AND PATIENT IS HEMODYNAMICALLY STABLE CURRENTLY. REFERENCE IAB CATHETER MFG REPORT # 2248146-2024-0000574.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091141 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 57 YR Male SENSATION PLUS 8FR 50CC IAB