BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18672660 · Received February 8, 2024

    Report

    Report Number
    2249723-2024-00521
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 30, 2024
    Report Date
    December 26, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (B4, D1, D2, D3, D4, G3, G4, G6, H2, H5, H10, H11).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G1, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: H1. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND THE FSE VERIFIED SHUTDOWN ERRORS IN LOGS RELATED TO CORRUPT VIDEO PROCESSER PCB (0040-00-0456) AND FAULT CODES 111/112. THE FSE REPLACED VIDEO BOARD. DURING TROUBLESHOOTING, THE FSE ALSO REPLACED SAFETY DISK (0202-00-0140) DUE TO PNEUMATIC FAILURE. FOLLOWING RECALIBRATION AND FUNCTIONAL TESTING, THE DEVICE WAS CYCLED ON CATHETER FOR 36 HOURS AFTER REPAIR WAS COMPLETED WITH NO FURTHER ERRORS TO REPORT. UNIT RELEASED BACK TO CLINICAL USE. THE VIDEO GENERATOR BOARD WAS RECEIVED AND INSPECTED BY GETINGE. VISUALLY, THE BOARD WAS FOUND IN GOOD CONDITION. WHEN INSTALLED INTO THE CARDIOSAVE TEST FIXTURE, THE UNIT WORKED CORRECTLY AND DID NOT SHUT DOWN. THE BOARD WAS SENT TO THE SUPPLIER FOR FURTHER ANALYSIS, WHICH FOUND THAT THE PART FAILED FUNCTIONAL COMPONENT TESTING AND HAD A FAULTY U41 COMPONENT (MICROCHIP TOUCHSCREEN CONTROLLER). FAULT CODES 111/112 ARE ASSOCIATED WITH A COMMUNICATION ERROR BETWEEN THE COMPONENTS OF THE PUMP LEADING TO SHUTDOWN OF THE PUMP. CAPA 284296 HAS INVESTIGATED THIS FAILURE AND INCLUDES SOFTWARE UPGRADES (D.00/D.01) TO MITIGATE THIS ERROR CODE. SOFTWARE IMPLEMENTATION IN THE US IS CURRENTLY PENDING REGULATORY APPROVALS. THIS FAILURE MODE IS ASSOCIATED WITH FIELD ACTION 2249723-01/24/2023-002-C. CAPA 802446 HAS INVESTIGATED DISPLAY RELATED FAILURES AND WILL IMPLEMENT A REDESIGNED VIDEO GENERATOR BOARD INCLUDING A NEW U41 CHIP.

    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 USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT SHUT DOWN. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50840 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