BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET WITH ARREST AGENT AND ADDITIV

    MDR report key: 2103392 · Received May 17, 2011

    Report

    Report Number
    1649914-2011-00004
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 16, 2011
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE FAILURE DID NOT CONTRIBUTE TO AN EVENT. THERE WERE NO PATIENT COMPLICATIONS. AFTER EVALUATION OF THE DEVICE THE ROOT CAUSE WAS DETERMINED TO BE DUE TO MANUFACTURING PROCESS TECHNIQUE. LINE LEADERS AND OPERATORS WERE TRAINED ON (B)(4) 2011 PER QUEST SKILLS DOCUMENT (B)(4) METHOD. THE TRAINING REINFORCED THE PROPER TECHNIQUE TO USE WHEN SOLVENT BONDING TUBING TO TUBING CONNECTIONS.

    Description of Event or Problem · 1

    USER FACILITY REPORTED NOTICING A BLOOD LEAK COMING FROM THE BUSHING/TUBING CONNECTION OF THE PUMP CASSETTE DURING CARDIOPLEGIA DELIVERY. THE LEAK WAS NOTICED 30 MINUTES INTO THE CASE. THE ARREST AGENT HAD BEEN DELIVERED AND RETROGRADE WAS BEING GIVEN AT 98-100 ML PER MINUTE. THE BLOOD INLET WAS CLAMPED, THE SET WAS CHANGED OUT, AND THE SURGERY CONTINUED. THE PATIENT WAS OFF THE PUMP 5-7 MINUTES DURING THE CHANGE OUT. THE PATIENT DID FINE; THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS DELIVERY SET WITH ARREST AGENT AND ADDITIV MPS DELIVERY SET DTR QUEST MEDICAL, INC. 5001102 0393431M09

    Patients

    Seq Age Sex Outcome Treatment
    1