BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 20085551 · Received August 28, 2024

    Report

    Report Number
    9611109-2024-00385
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 22, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTQ
    UDI-DI
    04033817902737
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO KNOWN PATIENT INVOLVEMENT. G.5. THE S5 DOUBLE HEAD PUMP 10-85-00Z IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO S5 DOUBLE HEAD PUMP 10-85-00, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K071318). THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNT THAT THE ALARM OCCURRED DURING FIRST PROCEDURE AFTER INSTALLATION. 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

    THE DISTRIBUTOR ENGINEER ON SITE INSPECTED THE UNIT AND TESTED IT SWAPPING COMPONENTS TO SPARE PARTS TO DETERMINE WHICH WAS DAMAGED AND FOUND THAT POWER AMPLIFIER MOTOR HMF 0408 AND THE RP 85 PUMP HEAD OF PUMP 2A WERE FAULTY. PUMP WAS RETURNED TO MUNICH FOR REPAIR. UPON INSPECTION ERROR COULD BE CONFIRMED: MESSAGE "FAULT IN MOTOR CONTROLLER 431 PUMP 2A" WAS DISPLAYED AT THE POWER ON OF THE PUMP, RESULTING IN NO CONTROL ON PUMP 2A (WHEREAS PUMP 2B WAS WORKING PROPERLY). AFTER SWAPPING THE CONNECTOR PUMP A AND B ON THE HKR BOARD, THE SAME FAILURE MESSAGE 431 OF PUMP 2A WAS DISPLAYED. IN ADDITION, THE MESSAGE "MOTOR MONITORING/CONTROL FAILED PUMP 2B" WAS DISPLAYED WITH PUMP 2B STOPPING TO WORK AFTER FEW SECOND FROM THE POWER ON. AS TROUBLESHOOTING THE HMF 0408 MOTOR AMPLIFIER BOARD, THE HMS 0409 MOTOR CONTROLLER AND THE PUMP HEAD WERE REPLACED. CONNECTORS OF PUMP A AND B WERE REESTABLISHED IN THE ORIGINAL CONFIGURATION AND UNIT RETURNED TO SERVICE AFTER FUNCTIONAL TEST PASSED POSITIVELY. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. BASED ON ALL THE ABOVE, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT HAS BEEN ASSIGNED TO AN ELECTRICAL FAILURE OF THE MOTOR AMPLIFIER BOARD AND THE PUMP HEAD OF PUMP 2A. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED A REPORT ABOUT CONSOLE ALARMS WITH "FAULT IN MOTOR CONTROLLER (431) PUMP 2A (BLOOD) , FAULT IN MOTOR CONTROLLER (433) PUMP 2A (BLOOD) AND FAULT IN MOTOR CONTROLLER (442) PUMP 2A (BLOOD)" WHEN TURNED ON. THE FIELD SERVICE ENGINEER HAS DONE THE SWAPPING PROCESS WITH OTHER SPARE PARTS TO DETERMINE WHICH SPARE PARTS ARE DAMAGED. IT WAS CONCLUDED THAT THE DAMAGE WAS ON THE POWER AMPLIFIER MOTOR BOARD AND THE ROLLER PUMP 85 PUMP HEAD ROTOR IN PUMP 2A.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198428 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND GMBH 10-85-00Z 04033817902737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown