BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 4798840 · Received May 27, 2015

    Report

    Report Number
    1649914-2015-00038
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    April 22, 2015
    Report Date
    April 27, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION. DEVICE EVALUATION CONFIRMED THE PRESENCE OF PVC FILM IN THE ADDITIVE CASSETTE. THE FILM WAS TOO LARGE TO BE EXTRACTED THROUGH THE TUBING. MOST LIKELY THIS WAS TRIMMED PVC FILM THAT DUE TO STATIC ADHERED ITSELF TO THE CASSETTE DURING ASSEMBLY, AND WAS MISSED DURING INSPECTION.

    Description of Event or Problem · 1

    THE FOREIGN ((B)(4)) DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WITH THE MPS DELIVERY SET. THEY REPORTED THAT WHEN THE CUSTOMER WAS FILLING THE ADDITIVE CASSETTE WITH SOLUTION, THEY OBSERVED A SMALL PIECE OF TRANSLUCENT, FOREIGN MATTER RESEMBLING A PLASTIC FILM FLOATING IN THE SOLUTION IN THE CASSETTE. IT WAS REPORTED THAT AS A RESULT OF THE OBSERVATION THE CUSTOMER USED ANOTHER DISPOSABLE SET INSTEAD. THERE WERE NO COMPLICATIONS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343864 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0482465J04

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention