BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18190696 · Received November 22, 2023

    Report

    Report Number
    2249723-2023-04967
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    November 13, 2023
    Report Date
    October 1, 2024
    Manufacturer
    DATASCOPE CORP.
    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

    TO FIX THE ISSUE, THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SAFETY DISK. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF PIM LEAK TEST FAILURE. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE SAFETY DISK TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER. THE FAT WAS ABLE TO REPLICATE THE CUSTOMER FAILURE OF THE PIM FAILING THE LEAK TEST. THE PIM FAILED THE MEMBRANE DIFFERENTIAL LEAK TEST WITH A RESULT OF 7 MMHG. THE FACTORY SPECIFICATION IS +- 6MMHG. THE SAFETY DISK FAILED TESTING. RETAINING THE SAFETY DISK IN THE FAT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    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) HAD A SAFETY DISK OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674553 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown