BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET W AA AND ADD CASSETTES

    MDR report key: 3368211 · Received September 11, 2013

    Report

    Report Number
    1649914-2013-00058
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 22, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED AN ISSUE WITH AN MPS DISPOSABLE DELIVERY SET DURING A PROCEDURE. THE PERFUSIONIST REPORTED THEY OBSERVED A LEAK IN THE DISPOSABLE SET. IT WAS REPORTED THEY CONTINUED THE PROCEDURE WITH THE SAME SET AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PT COMPLICATIONS. THE COMPLAINT SAMPLE WAS RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456572 MPS DELIVERY SET W AA AND ADD CASSETTES CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0444983E02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention