BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16645742 · Received March 30, 2023

    Report

    Report Number
    2249723-2023-01692
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 21, 2023
    Report Date
    October 28, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER EVALUATED THE UNIT, AND REPLACED DRIVE MANIFOLD ASSEMBLY(D104-00-0031) ON UNIT. ALL MANIFOLDS TESTING PASSED. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS PERFORMED. UNIT WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. THE FOLLOWING WAS PERFORMED BY THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0104-00-0031 SN: (B)(6) DRIVE MANIFOLD THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF FAILED THE DRIVE MANIFOLD LEAK TEST. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN CONDITION. INSTALLED THE DRIVE MANIFOLD INTO THE CARDIOSAVE TEST FIXTURE SN (B)(6) AND TESTED TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION D AND THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION R. THE FAILURE ANALYSIS AND TESTING DEPARTMENT VERIFIED THE FAILURE OF DRIVE MANIFOLD LEAK DIFF. PRESSURE TEST FAILED WITH RESULT OF 29 MMHG; THE FACTORY SPECIFICATION IS +-25 MMHG. DRIVE MANIFOLD FAILED TESTING. RETAINING DRIVE MANIFOLD IN THE FAT DEPT. AS PER PROCEDURE 0002-07-D008 REV AN. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0104-00-0031 DRIVE MANIFOLD SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF FAILED DRIVE MANIFOLD TEST. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION OF THE DRIVE MANIFOLD WHICH INCLUDED THE INSPECTION OF ALL ELECTRICAL WIRING AND COMPONENTS. THE FAT DEPT. FOUND ALL ELECTRICAL WIRING AND COMPONENTS TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0104-00-0031 DRIVE MANIFOLD SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE DRIVE MANIFOLD TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE DRIVE MANIFOLD TEST WAS PERFORMED. THE DRIVE MANIFOLD FAILED THE VACUUM LEAK DIFFERENTIAL TEST WITH A RESULT OF 44MMHG. THE FACTORY SPECIFICATION IS +-25MMHG. THE DRIVE MANIFOLD ALSO FAILED THE PRESSURE LEAK DIFFERENTIAL TEST WITH A RESULT OF -81MMHG. THE FACTORY SPECIFICATION IS +-55MMHG. THE DRIVE MANIFOLD FAILED TESTING. RETAINING THE DRIVE MANIFOLD IN THE FAT DEP. PER PROCEDURE NUMBER 0002-07-D008 REV. AR.

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592352 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