BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HL20 BUBBLE SENSOR

    MDR report key: 4475677 · Received January 30, 2015

    Report

    Report Number
    8010762-2015-00044
    Event Type
    Malfunction
    Date Received
    January 30, 2015
    Date of Event
    January 1, 2015
    Report Date
    January 30, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS WITH SIMILAR MALFUNCTION. NO ANALYSIS CAN BE DONE FOR THE SAID DEVICE AS IT HAS BEEN CONTINUED TO BE USED UNTIL THE CASE WAS DONE AND IS STILL IN USE. NO SERVICE HAS BEEN DONE ON THE DEVICE. MANY REQUESTS FOR INFORMATION WERE NOT SUCCESSFUL. NO SERIAL NUMBER OF THE DEVICE IS AVAILABLE. THEREFORE NO INVESTIGATION WILL BE DONE. THE DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME. THE MOST PROBABLE ROOT CAUSE COULD BE A DEFECTIVE BUBBLE SENSOR.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN EVALUATED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE. THE PRODUCT REPORTED IN SECTION D IS A COMPONENT OF THE HL-20 INTEGRATED PERFUSION SYSTEM CLEARED UNDER 510(K) K94383.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUBBLE DETECTOR ON THE ROTAFLOW WAS WORKING PROPERLY, BUT THE BUBBLE SENSOR ON THE CONTROL PANEL KEPT ALARMING THAT BUBBLES WERE PRESENT DURING PT THERAPY. THE DEVICE CONTINUED TO BE USED UNTIL THE CASE WAS COMPLETED. NO REPORTED PT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71102 HL20 BUBBLE SENSOR MCP00923371#BSC 20-500 BUBBLE SENSOR DTQ MAQUET CARDIOPULMONARY AG BSC 20-500

    Patients

    Seq Age Sex Outcome Treatment
    1