BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 1853752 · Received September 2, 2010

    Report

    Report Number
    8030665-2010-00021
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 6, 2010
    Report Date
    September 3, 2010
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THE FOLLOWING EVENT. THE BLOOD LINE SEPARATED AT THE JUNCTURE OF THE ARTERIAL SEGMENT INTO SALINE T SEGMENT DURING TREATMENT AND THAT THEY WERE UNABLE TO REMOVE THE BLOOD TO SEND FOR AN EVALUATION. THE FACILITY WAS CONTACTED FOR ADDITIONAL INFORMATION FOR THIS EVENT. IN SPEAKING WITH THE REPORTER IT WAS LEARNED THAT THIS EVENT OCCURRED ON THE ARTERIAL BLOODLINE AND OCCURRED AT 30 MINUTES INTO THE DIALYSIS TREATMENT. IT WAS REPORTED THIS EVENT RESULTED IN A TOTAL EBL OF <275 ML. NO BLOOD WAS RETURNED TO THE PATIENT. THE NURSE SET UP A BRAND NEW TREATMENT SET AS WELL AS A NEW DIALYZER AND THE PATIENT COMPLETED THE REMAINDER OF THE TREATMENT WITHOUT FURTHER INCIDENT. REPORTEDLY, THE PATIENT IS FINE AND HAD NO ILL EFFECT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET HEMODIALYSIS BLOODLINES FJK REYNOSA MANUFACTURING NA 10ER01032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA