BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 13168337 · Received January 5, 2022

    Report

    Report Number
    9611109-2022-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 8, 2021
    Report Date
    January 5, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP 60-01-00 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP 60-02-15, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K032213). LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. THE FAILURE WAS TRACED BACK TO THE MOTOR CONTROL BOARD WHICH WAS REPLACED TO SOLVE THE REPORTED FAILURE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H.10: THE ROOT CAUSE OF THE REPORTED ISSUE IS A DEFECTIVE MOTOR CONTROL BOARD.

    Description of Event or Problem · 0

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP WENT FROM 2000 RPM DOWN TO 1000 RPM DURING SERVICE. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226522 CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown