BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCP00151005# CLS 20-535 CAPACITIVE LEVEL SENSO

    MDR report key: 4562021 · Received February 26, 2015

    Report

    Report Number
    8010762-2015-00222
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    November 17, 2014
    Report Date
    November 18, 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 DEFECTIVE LEVEL SENSOR AND REPLACED. SATISFACTORILY PERFORMED COMPLETE PERFORMANCE AND FUNCTION TESTING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE PRODUCT REPORTED IN BLOCK D WAS IN USE ON A HL20 4 PUMP CONSOLE, MODEL 3 70104.3253, SERIAL #(B)(4). BOTH PRODUCTS ARE COMPONENTS OF THE INTEGRATED PERFUSION SYSTEM CLEARED UNDER 510 (K) K943803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RETROGRADE PRIMING, THE LEVEL SENSOR FAILED TO INDICATE/ALARM OR SURVOREGULATE CARDIOTOMY LEVEL WHEN IT WENT BELOW SENSOR POSITION. CASE CONTINUED SINCE THEY WERE ON BYPASS BUT HAD TO CONSTANTLY WATCH THE CARDIOTOMY LEVEL DURING THE CASE. NO REPORTED PATIENT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137686 MCP00151005# CLS 20-535 CAPACITIVE LEVEL SENSO DTQ MAQUET CARDIOPULMONARY AG 70101.0855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other