BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMING SET FOR ARTERIAL BLOODLINES

    MDR report key: 3703053 · Received January 9, 2014

    Report

    Report Number
    8030665-2014-00019
    Event Type
    Malfunction
    Date Received
    January 9, 2014
    Date of Event
    December 2, 2013
    Report Date
    December 10, 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 WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION. RELATED MDRS: 8030665-2014-00012, 8030665-2014-00013, 8030665-2014-00014, 8030665-2014-00015, 8030665-2014-00016, 8030665-2014-00017, 8030665-2014-00018, 8030665-2014-00019, 8030665-2014-00020, 8030665-2014-00021, 8030665-2014-00022, 8030665-2014-00023, 8030665-2014-00024, 8030665-2014-00025, 8030665-2014-00026, 8030665-2014-00027, 8030665-2014-00028, 8030665-2014-00029, 8030665-2014-00030, 8030665-2014-00031, 8030665-2014-00032, 8030665-2014-00033, 8030665-2014-00034, 8030665-2014-00035.

    Description of Event or Problem · 1

    AS PER DETAILS GIVEN BY NURSE "LINES ARE NOT ONLY LEAKING AT THE CONNECTION SITE OF THE MALE PORT, BUT ALSO THE Y BETWEEN THE PIGGY TAIL AND MAIN PRIME LINE." NURSE WAS CONCERNED THAT THIS CREATES AN OPEN SYSTEM AND COULD LIKELY INCREASE THE LIKELIHOOD FOR INFECTION. SHE ALSO MENTIONED THAT IT CREATES A FLUID SENSOR ALARM ON THE MACHINE. NO PATIENT ILL EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17981 PRIMING SET FOR ARTERIAL BLOODLINES KOC REYNOSA MANUFACTURING 13KR01247

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(6)| 5008 MACHINE