BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17362550 · Received July 20, 2023

    Report

    Report Number
    2249723-2023-03258
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    July 5, 2023
    Report Date
    February 15, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS; B4, D9, G3, G6, H2, H3, H4, H6, H10. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE ISSUE. UPON ARRIVAL, THE FSE RAN THE UNIT ON THE TEST CIRCUIT AND FOUND NO ISSUE. THE FSE FOUND FAULT 77 "COMPRESSOR MOTOR SPEED ADJ- ASSISTING" LOGGED ONCE AND IS THE ONLY TECHNICAL FAULT LOGGED. PER THE SERVICE MANUAL "NO ACTION REQUIRED". ALSO, THE FSE STATED THAT THE CLINICAL ALARM HISTORY SHOWED THE "AUGMENTATION BELOW LIMIT SET" ALARM 6 TIMES AND "IAB DISCONNECTED" ONCE, ON THE DAY OF THE EVENT. NO ISSUES WERE FOUND WITH THE UNIT. THE FSE PERFORMED A PM, A FULL CALIBRATION, AND TESTED THE UNIT. THE UNIT WORKED TO MANUFACTURER¿S SPECS. THE UNIT WAS CLEARED FOR CLINICAL USE AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS REPORTED TO BE MAKING A HISSING NOISE AND THEN HAD STOPPED PUMPING, THE PATIENT WAS PLACED ON THE IABP TO STABILIZE FOR SURGERY. APPROXIMATELY TWENTY MINUTES AFTER BEING ON THE IABP, THE UNIT STARTED MAKING A HISSING NOISE LIKE IT WAS LOOSING AIR. THE ATTACHMENTS WERE CHECKED AND NO LEAK WAS NOTED. THE BALLOON STARTED TO NOT INFLATE ANYMORE. PATIENT WAS SWITCHED TO A NEW MACHINE BUT IN THE MEAN TIME HAD LOST A PULSE AND A CODE WAS CALLED, CPR WAS PERFORMED ON THE PATIENT RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED. THE NEW UNIT WAS WORKING PROPERLY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124011 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 NA Unknown Required Intervention