BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HL-20 INTEGRATED PERFUSION SYSTEM

    MDR report key: 5836696 · Received August 1, 2016

    Report

    Report Number
    8010762-2016-00494
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 18, 2016
    Report Date
    July 18, 2016
    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

    THE DEFECTIVE PART HAS BEEN INVESTIGATED IN OUR LABORATORY AS FOLLOWS: THE FAILURE IS REPRODUCIBLE. THE TRANSISTOR T6 ¿BC847B¿ IS DEFECT; THEREFORE NO SUPPLY VOLTAGE IS AVAILABLE FOR THE LEVEL SENSOR. DUE TO THE OSCILLATING OUTPUT ON IC 21B, WITHOUT THE LEVEL SENSOR, THE TRANSISTOR T6 CAN BE DAMAGED. ALSO IC 20 IS DEFECT IT HAS NO OUTPUT VOLTAGE. A CAPACITOR OF 1 NF BETWEEN PIN 1 & 2 AS WELL BETWEEN PIN 7 & 5 CAN STOP THE OSCILLATIONS FROM THE IC21 OUTPUT. THUS THE FAILURE COULD BE CONFIRMED. SOLDERING WAS PERFORMED ON THE CIRCUIT BOARD DURING INVESTIGATION TO FIND THE MOST POSSIBLE ROOT CAUSE. IC 20 DEFECT. 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

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT DURING PRIMING OF THE SYSTEM THE LEVEL DETECTOR WOULD NOT FUNCTION. NO KNOWN CONSEQUENCES TO THE PATIENT. NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490929 MAQUET HL-20 INTEGRATED PERFUSION SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG MCP00706197

    Patients

    Seq Age Sex Outcome Treatment
    1