BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HL20 INTEGRATED PERFUSION SYSTEM

    MDR report key: 5166471 · Received October 21, 2015

    Report

    Report Number
    8010762-2015-01118
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Date of Event
    September 22, 2015
    Report Date
    September 22, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SERVICE ORDER NO. (B)(4). FIELD SAFETY TECHNICIAN WAS SENT FOR INVESTIGATION AND FOUND TWIN PUMP DISPLAYS ERROR CODE ON LEFT DISPLAY. THE CONTROL BOARD HAS BEEN REPLACED AND FOUND OK. THUS THE FAILURE COULD BE CONFIRMED. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE ISSUE HAS BEEN REEVALUATED WITH THE RESULT THAT THIS ISSUE "EPROM ERROR ON HL20" IS NOT REPORTABLE. AS THE EPROM ERROR IS PART OF THE SELF TEST OF THE HL20, WHICH IS ALWAYS PERFORMED PRIOR TO USE (DURING STARTUP OF THE DEVICE, AND THE EPROM IS NOT TESTED AT ANY LATER POINT IN TIME, IT CAN BE EXCLUDED THAT THE ERROR WILL OCCUR DURING PATIENT TREATMENT. ADDITIONAL BASED ON THE TREND SEARCH ANALYSIS NO COMPLAINT WAS FOUND WITH THE MENTIONED ISSUE HAPPENED DURING PATIENT TREATMENT. ALL REPORTED ISSUES OCCURRED PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AFTER RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "THE ROLLER PUMP SHOWS ERROR MESSAGE ERROR EPROM" THIS HAPPENED DURING MAINTENANCE / SERVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695602 HL20 INTEGRATED PERFUSION SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG 70102.7652

    Patients

    Seq Age Sex Outcome Treatment
    1