BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCP00151005#CLS 20-535 CAPACITIVE LEVEL SENSOR

    MDR report key: 4552871 · Received February 24, 2015

    Report

    Report Number
    8010762-2015-00102
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET SERVICE TECHNICIAN VERIFIED THE PROBLEM. TROUBLESHOT TO A DEFECTIVE LEVEL SENSOR AND REPLACED. SUCCESSFULLY PERFORMED COMPLETE PERFORMANCE AND FUNCTIONAL TESTING. THE PRODUCT IN BLOCK D WAS IN USE ON A HL20 4 PUMP CONSOLE MODEL # 701104.3253, SERIAL # (B)(4). BOTH ARE COMPONENTS OF THE HL20 INTEGRATED PERFUSION SYSTEM CLEARED UNDER 510 (K) K943803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEVEL SENSOR ON THE CARDIOTOMY RESERVOIR DID NOT ALARM OR SERVO REGULATE WHEN THE VOLUME WENT BELOW THE LEVEL THE SENSOR WAS POSITIONED AT. THIS OCCURRED ON TWO SEPARATE OCCASIONS. NO REPORTED PT EFFECT. THIS EVENT IS REPLATED TO MEDWATCH REPORT # 8010762-2015-00113. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127501 MCP00151005#CLS 20-535 CAPACITIVE LEVEL SENSOR DTQ MAQUET CARDIOPULMONARY AG 70101.0855

    Patients

    Seq Age Sex Outcome Treatment
    1