BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMING SET FOR ARTERIAL BLOODLINES

    MDR report key: 3791887 · Received January 22, 2014

    Report

    Report Number
    8030665-2014-00064
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    December 2, 2013
    Report Date
    December 23, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    KOC
    PMA / PMN Number
    K010268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR PHYSICAL EVALUATION. A PLANT INVESTIGATION IS STILL ONGOING AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING TREATMENT, THE SET LEAKED AT THE CONNECTOR NEAREST TO THE PATIENT BLOODLINE AND THE PATIENT LOST A CIRCUIT OF BLOOD. THE MACHINE ALARMED. TREATMENT WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT PRIMING SET. THE PATIENT WAS ASYMPTOMATIC, DID NOT REQUIRE MEDICAL INTERVENTION, AND WAS FINE. SAMPLE DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53453 PRIMING SET FOR ARTERIAL BLOODLINES KOC REYNOSA MANUFACTURING 13DR01024

    Patients

    Seq Age Sex Outcome Treatment
    1