BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCP00706035#ROTAFLOW ENGLISH/US US-PLUG

    MDR report key: 4771925 · Received May 12, 2015

    Report

    Report Number
    8010762-2015-00451
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    December 1, 2014
    Report Date
    December 1, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROTAFLOW CONSOLE(RFC)WAS REQUESTED AND RETURNED TO RASTATT FOR INVESTIGATION. THE RFC WAS THOROUGHLY INVESTIGATED WHERE THE RFC WAS TESTED IN CONJUNCTION WITH AN HL20 DEVICE UNDER SEVERAL CONDITIONS. HOWEVER, THE REPORTED ERROR MESSAGE ("STOP") COULD NOT BE REPRODUCED. IT WAS CONCLUDED THAT THE RFC COULD BE RE-USED AS NO FAULT COULD BE FOUND WITH THE COMPONENT. THIS FOLLOW UP REPORT WILL ALSO SERVE AS THE FINAL REPORT FOR THIS REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE INVESTIGATION OF THE REPORTED PROBLEM IS STILL PENDING. A SUPPLEMENTAL- MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(4). THE INITIAL MEDWATCH FOR THIS COMPLAINT WAS SUBMITTED ON PAPER UNDER MFR REPORT # 8010762-2015-00451.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN RUNNING ALL PUMP HEADS OF A HL20 5 PUMP CONSOLE THE ROTAFLOW DISPLAYS THE ALARM "STOP." (B)(4). (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311332 MCP00706035#ROTAFLOW ENGLISH/US US-PLUG CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG US-PLUG

    Patients

    Seq Age Sex Outcome Treatment
    1