BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16356455 · Received February 10, 2023

    Report

    Report Number
    2249723-2023-01039
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 27, 2023
    Report Date
    January 10, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED THE MEMBRANE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT. THE FSE THAT ENCOUNTERED THE ISSUE REPLACED THE SAFETY DISK. THE FSE PERFORMED A COMPLETE PM WITH FULL CALIBRATION, FUNCTIONAL TESTING, AND SAFETY CHECKS TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FOLLOWING WAS PERFORMED BY THE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: SAFETY DISK THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF FAILED MEMBRANE LEAK TEST. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN GOOD CONDITION. INSTALLED THE SAFETY DISK INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. THE FAILURE ANALYSIS AND TESTING DEPARTMENT VERIFIED THE FAILURE OF THE SAFETY DISK FAILING THE MEMBRANE LEAK TEST, WITH A RESULT OF 9MMHG. THE FACTORY SPECIFICATION IS +-6MMHG. THE SAFETY DISK FAILED TESTING. RETAINING THE SAFETY DISK 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

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT FAILED THE MEMBRANE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49322 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 Unknown N/A.