BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16528755 · Received March 13, 2023

    Report

    Report Number
    2249723-2023-01460
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 1, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND WHILE PERFORMING THE PIM LEAK TEST THE FSE FOUND THAT THE 3RD LEAK TEST FAILED. THE FSE REPLACED THE PIM. PERFORMED ALL FUNCTIONAL AND SAFETY TESTS. ALL TESTS PASS. RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. THE REMOVED PIM WAS RETURNED TO THE FAILURE ANALYSIS AND TESTING DEPARTMENT(FAT) FOR INVESTIGATION. FAT PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN GOOD CONDITION. INSTALLED THE PIM INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE FACTORY SPECIFICATIONS AND THE CARDIOSAVE SERVICE MANUAL. THE FAILURE ANALYSIS AND TESTING DEPARTMENT VERIFIED THE FAILURE OF FAILING LEAK DIFF. TEST WITH RESULT OF -42MMHG, THE FACTORY SPECIFICATION IS +-10MMHG. THE PIM FAILED TESTING. RETAINING THE PIM IN THE FAT DEPT. AS PER PROCEDURE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A GAS LEAK. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448432 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