BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 17824777 · Received September 27, 2023

    Report

    Report Number
    9611109-2023-00468
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    August 29, 2023
    Report Date
    January 16, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    UDI-DI
    04033817900382
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2015 AND NO OTHER SIMILAR EVENT HAS BEEN REPORTED, NEITHER CONCERNING TREND HAS BEEN IDENTIFIED. BASED ON THE OUTCOME OF SERVICE ACTIVITY, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ASSIGNED TO AN ELECTRICAL FAILURE OF THE BOARD DUE TO OXIDATION AND CORROSION, LIKELY DUE TO AGING AND WEAR OF COMPONENTS. THE WEARING OF ELECTRO-MECHANICAL DEVICE CAN BE ORIGINATED BY THE SPECIFIC USE CONDITION AT CUSTOMER SITE AND MAY HAVE CONTRIBUTED TO THE EVENT, HOWEVER THERE IS NO CONCERNING TREND FOR THIS KIND OF FAILURE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    A LIVANOVA FIELD SERVICE ENGENEER WAS DISPATCHED TO THE CUSTOMER SITE AND COULD NOT REPRODUCE ERROR. PULLED HKD BOARD AND DISCOVERED SOME CORROSION ON SOME TRACES OF THE LEDS ON THE BOARD. CLEANED BOARD AND RE-INSTALLED. REPLACED BATTERIES. PERFORMED ALL FUNCTIONAL VERIFICATION, ALL TESTED WITHIN SPECIFICATIONS. UNIT 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

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN EL PASO, TEXAS. THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA LEARNED THAT THE ERROR MESSAGE WAS DISPLAYED AFTER GOING ON PUMP AND TURNING ROLLER HEAD ON. THE ERROR WAS NOT DISPLAYED DURING PRE-FUNCTIONAL CHECK (PUMP OCCLUSION TEST) PERFORMED BY THE PERFUSIONIST. IN ADDITION, IT WAS LEARNED THAT THE AFFECTED PUMP WAS NOT USED ON THE PATIENT AND REPLACED WITH ANOTHER ONE. THE CASE CONTINUED WITH NO PATIENT IMPACT. REPORTED ERROR SIGNALS THAT LED DISPLAY ON PUMP CONTROL PANEL REMAINS DARK. POSSIBLE CAUSES ARE: CONNECTIONS TO CIRCUIT BOARD KEYS AND LEDS INTERRUPTED; FAULT IN CIRCUIT KEYS AND LEDS BOARD HKD; FAULT IN COMPUTER BOARD HKR. 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP DID NOT WORK AND GAVE AN ERROR MESSAGE RELATED TO SETTING KNOB LED FAILURE DURING PROCEDURE.THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019136 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 10-80-00 04033817900382

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown