BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCP WITH TUBING CLAMP

    MDR report key: 16960610 · Received May 19, 2023

    Report

    Report Number
    9611109-2023-00227
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 19, 2023
    Report Date
    August 10, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    UDI-DI
    04033817901068
    PMA / PMN Number
    K032213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ERC TUBING CLAMP. THE INCIDENT OCCURRED IN UNITED STATES. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    BASED ON ALL COLLECTED INFORMATION AND TAKING INTO ACCOUNT SIMILAR COMPLAINTS, THE ROOT CAUSE OF THE REPORTED ISSUE COULD BE TRACED BACK TO: MECHANICAL FAULT (BLOCKED CLAMP SPINDLE #60-05-13). DEFECTIVE HALL SENSORS LOCATED IN THE ERC STATOR #97-103-645. A DEFECTIVE ZKA #90-305-310 OR ZKB #90-305-320 BOARD. BASED ON THE ABOVE, AN ISOLATED EARLY FAILURE OF THE AFOREMENTIONED COMPONENTS CANNOT BE RULED OUT AS THE ROOT CAUSE OF THE REPORTED ERROR MESSAGE. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY.

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW-UP COMMUNICATION WITH LIVANOVA FIELD SERVICE REPRESENTATIVE, IT WAS LEARNED THAT CP5 DRIVE WAS REPLACED SINCE IT WAS DAMAGED FROM MISUSE, THE PLASTIC PART THAT HOLDS THE DISPOSABLE WAS CRACKED/BROKEN. ALSO THE WHEEL WAS REPLACED SINCE IT WAS BROKEN. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    A LIVANOVA FIELD SERVICE ENGENEER WAS DISPATCHED TO THE CUSTOMER SITE AND CP DRIVE, ERC AND WHEEL REPLACED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT OF A DEFECTIVE ARTERIAL CLAMP DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248484 SCP WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 48-40-00 60S24024 04033817901068
    622221 SCP WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 48-40-00 60S24024 04033817901068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown