BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19667399 · Received July 3, 2024

    Report

    Report Number
    2249723-2024-02711
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 14, 2024
    Report Date
    September 25, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    CORRECTED FIELDS; D4. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS BEING DISPATCHED IN ORDER TO EVALUATE THE UNIT AND DURING THE PERIOD OF AN EVALUATION FSE HAD FOUND THAT THE SAFETY DISK HAD FAILED THE MEMBRANE LEAK TEST (-13). THEN THE FSE HAD REPLACED THE ASSEMBLY, SAFETY DISK WHICH HAD CORRECTED THE ISSUE. AFTER THE REPLACEMENT THE DEVICE HAD PASSED ALL THE FUNCTIONAL AND SAFETY TESTS ACCORDING TO THE FACTORY SPECIFICATIONS. THE FOLLOWING INVESTIGATION WAS PERFORMED BY A TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) (B)(4), NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED A SAFETY DISK WITH A REPORTED UNIT FAILURE OF FAILING THE MEMBRANE LEAK TEST. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED SAFETY INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE SAFETY DISK TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. THE FAT DEPT. PERFORMED THE SAFETY DISK LEAK TEST IN DIAGNOSTICS. THE FAT DEPT. COULD NOT REPLICATE THE COMPLAINT OF THE SAFETY DISK FAILING THE MEMBRANE LEAK TEST. THE MEMBRANE LEAK TEST RESULT WAS -3MMHG. FACTORY SPECIFICATION IS +-10MMHG.THE SAFETY DISK PASSED TESTING. RETAINING THE SAFETY DISK IN THE FAT DEPT. PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A ROUTINE CHECK , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SAFETY DISK FAILS MEMBRANE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508175 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