BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 11051001 · Received December 21, 2020

    Report

    Report Number
    9611109-2020-00702
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 21, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE REPORTED ERROR CODE COULD NOT BE REPRODUCED. HOWEVER, THE PROCESSOR BOARD WHERE THE EPROM IS LOCATED WAS REPLACED AS POTENTIALLY INVOLVED COMPONENT. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS A FAILURE OF THE EPROM ON THE PROCESSOR BOARD.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP WAS USED AS BACK UP DURING A PROCEDURE AND DISPLAYED AN ERROR CODE ASSOCIATED TO THE EPROM WHEN TURNED ON. REPORTEDLY THE PROCEDURE COULD BE COMPLETED WITH NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513245 CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 60-02-50

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown