BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMING SET FOR ARTERIAL BLOODLINES

    MDR report key: 3911943 · Received May 13, 2014

    Report

    Report Number
    8030665-2014-00387
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    December 11, 2013
    Report Date
    April 15, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    KOC
    PMA / PMN Number
    K010268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT, A ROLLER CLAMP WAS NOT TIGHT ENOUGH AS THE PORT PLUG DELIVERS MEDICATION AND LETS THE AIR ACCUMULATE IN THE CIRCUIT. THE FACILITY REPORTED THAT 50% OF THE TIME, THE PATIENT LOST A CIRCUIT OF BLOOD AND THE OTHER 50% SALINE WAS USED TO RETURN BLOOD BACK TO THE PATIENT. THEY PERFORM 3-4 TREATMENTS PER WEEK AND THIS INCIDENT OCCURRED EVERY TIME THIS PRIMING SET WAS USED. PATIENT HAD NO ADVERSE EFFECTS AND REQUIRED NO MEDICAL INTERVENTION. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER. THIS IS ONE OF 42 COMPLAINTS REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285296 PRIMING SET FOR ARTERIAL BLOODLINES KOC REYNOSA MANUFACTURING 13DR01024

    Patients

    Seq Age Sex Outcome Treatment
    1