BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS DELIVERY SET W AA AND ADD CASSETTES

    MDR report key: 2920089 · Received December 14, 2012

    Report

    Report Number
    1649914-2012-00036
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    May 1, 2011
    Report Date
    May 12, 2011
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION - DEVICE EVAL FOUND THE ROOT CAUSE TO BE INSUFFICIENT SOLVENT-BONDING WHERE THE BLOOD SOURCE TUBE-LINE CONNECTS TO THE BUSHING OF THE PUMP CASSETTE. A CORRECTIVE ACTION HAS BEEN IDENTIFIED AND IMPLANTED TO ADDRESS THE ROOT CAUSE. 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

    IT WAS REPORTED BY THE HOSP PERFUSIONIST THAT DURING A PROCEDURE, THE DELIVERY SET DISPOSABLE EXPERIENCED A LEAK IN THE TUBING AT THE CONNECTION POINT. THE PERFUSIONIST REPORTED THE PT LOST APPROX 100 CCS OF BLOOD DUE TO THE ALLEGED MALFUNCTION. IT WAS REPORTED THAT THE TUBING WAS CINCHED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PT COMPLICATIONS REPORTED. THE DISPOSABLE DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS DELIVERY SET W AA AND ADD CASSETTES CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0393451M12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention