BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 2142091 · Received May 26, 2011

    Report

    Report Number
    8030665-2011-00024
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 25, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT HAS BEEN RECEIVING HEMODIALYSIS TREATMENTS AT AN OUTPATIENT CLINIC. ON (B)(6) 2011 AT THE INITIATION OF TREATMENT THE COMBISET BLOOD TUBING SET SEPARATED AT THE VENOUS MED PORT AT THE DISTAL END FROM THE PATIENT. REPORTEDLY, THERE WAS A 100ML BLOOD LOSS AND THE REMAINING BLOOD WAS ABLE TO BE RETURNED TO THE PATIENT. THE VENOUS LINE WAS THEN CHANGED AND TREATMENT CONTINUED WITHOUT FURTHER INCIDENT. THE PATIENT WAS DISCHARGED FOLLOWING THE TREATMENT. THERE IS NO SAMPLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET HEMODIALYSIS BLOODLINE FJK REYNOSA MANUFACTURING NA 11CR01132

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR