BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERYSET W AA AND ADD CASSETTES

    MDR report key: 3055260 · Received December 18, 2012

    Report

    Report Number
    1649914-2012-00037
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL PERFUSIONIST THAT DURING A PROCEDURE THE DELIVERY SET DISPOSABLE EXPERIENCED A LEAK AT THE BLOOD INLET LINE TO THE PUMP CASSETTE. IT WAS REPORTED THAT THE SEAL WAS LOOSE, WHICH ALLOWED THE BLOOD TO LEAK. THE PERFUSIONIST STATED THE LEAK OCCURRED PRIOR TO THE SURGEON PUTTING ON THE CROSS-CLAMP. THE PROCEDURE WAS DELAYED WHILE A NEW DISPOSABLE SET WAS PREPARED FOR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DISPOSABLE DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS DELIVERYSET W AA AND ADD CASSETTES CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0426722G09

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention