BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HL-20 INTEGRATED PERFUSION SYSTEM

    MDR report key: 4285637 · Received December 1, 2014

    Report

    Report Number
    8010762-2014-00711
    Event Type
    Malfunction
    Date Received
    December 1, 2014
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS, AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE MAQUET SERVICE TECHNICIAN REPLACED THE QUAD TEMPERATURE MODULE (QTM) AND PERFORMED A FULL CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECIFICATIONS. THE DEFECTIVE QTM WAS NOT RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    ON (B)6) 2013, WHILE PERFORMING PREVENTIVE MAINTENANCE (PM), THE MAQUET SERVICE TECHNICIAN DISCOVERED THAT FOR THE RPC 20-121 2-PUMPS CONSOLE (ARTICLE NUMBER: 70102.8583, SERIAL NUMBER: (B)(4)) THE UNIT WAS NOT READING TEMPERATURES. THE CUSTOMER HAD NOT BEEN MONITORING TEMPERATURE WITH THE HL20 DURING CASES (THEY HAD USED THEIR HEATER UNIT TO MONITOR TEMPERATURES) AND HAD NOT NOTICED THE MALFUNCTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774071 HL-20 INTEGRATED PERFUSION SYSTEM CONSOLE, HEART/LUNG MACHINE DTQ MAQUET CARDIOPULMONARY AG MCP00703695

    Patients

    Seq Age Sex Outcome Treatment
    1