BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16869494 · Received May 4, 2023

    Report

    Report Number
    2249723-2023-02236
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    April 27, 2023
    Report Date
    January 3, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE HAD A FAILED LEAKAGE TEST AT 10MMHG. THE FSE REPLACED THE SAFETY DISK. THE FSE PERFORMED FUNCTIONAL TESTS AND ALL OTHER REQUIRED TESTS. THE IABP WAS CLEARED FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF FAILING THE LEAK TEST. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION OF THE 0202-00-0140 AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED THE SAFETY DISK INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE SAFETY DISK TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION D AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. AFTER PERFORMING THE ALL MANIFOLD TEST IT WAS OBSERVED THAT THE MEMBRANE DIFFERENTIAL PRESSURE TEST HAD FAILED WITH A RESULT OF 10MMHG. THE FACTORY SPECIFICATIONS IS +- 6MMHG. THE SAFETY DISK FAILED TESTING. RETAINING THE SAFETY DISK IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE PATIENT USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED THE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860312 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