BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 14292561 · Received May 5, 2022

    Report

    Report Number
    2249723-2022-01030
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 6, 2022
    Report Date
    March 16, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Removal / Correction Number
    2249723-01/24/2023-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP, AND REPLACED THE HELIUM REGULATOR WHICH CORRECTED THE ISSUE. THE FSE PERFORMED FUNCTIONAL TESTS THAT CARRIED OUT WITH POSITIVE RESULTS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. THE FULL NAME OF THE INITIAL REPORTER THAT IS ABBREVIATED IS (B)(6), WHO IS A GETINGE EMPLOYEE. A CONTACT PERSON AT THE EVENT SITE IS: (B)(6).

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET NATIONAL REPAIR CENTER (NRC). THE NRC RECEIVED A PRESSURE REGULATOR P/N 0103-00-0637, SERIAL NUMBER (B)(6), WITH A REPORT THE UNIT HAD A LOSS OF HELIUM FROM THE PRESSURE REGULATOR. PERFORMED VISUAL INSPECTION OF PRESSURE REGULATOR P/N 0103-00-0637, SERIAL NUMBER (B)(6) PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION Q AND FOUND NO VISUAL DAMAGE AND THE PART LOOKS TO BE IN GOOD CONDITION. INSTALLED THE PRESSURE REGULATOR P/N 0103-00-0637, SERIAL NUMBER (B)(6) INTO NRC IABP CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) FOR TESTING OF THE REPORTED PROBLEM. PERFORMED AND TESTED THE PRESSURE REGULATOR P/N 0103-00-0637, SERIAL NUMBER (B)(6) IN ACCORDANCE WITH PROCEDURE NUMBER (B)(6) REVISION C AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION Q, IN AN ATTEMPT TO RECREATE THE REPORTED PROBLEM, THE NRC VERIFY THAT UNIT HAD A LOSS OF HELIUM FROM THE PRESSURE REGULATOR. RETAINING THE PRESSURE REGULATOR IN THE NRC PER PROCEDURE (B)(6) REV AJ. IF FURTHER INVESTIGATION IS NOT REQUIRED, THE PRESSURE REGULATOR SHALL BE SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CUSTOMER DEMO THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A LOSS OF HELIUM FROM THE PRESSURE REGULATOR. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465039 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 N/A 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.