BEUDAMED
    FDA Adverse Event Death Summary report: N

    RCG COMBI SET

    MDR report key: 522515 · Received April 23, 2004

    Report

    Report Number
    8030665-2004-00039
    Event Type
    Death
    Date Received
    April 23, 2004
    Date of Event
    March 12, 2004
    Report Date
    April 23, 2004
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTS DURING A PHONE CONVERSATION IN 2004 VENOUS LINE DISCONNECTED FROM THE PT'S SUBCLAVIAN CATHETER DURING A DIALYSIS TREATMENT. FACILITY NOT ABLE TO ESTIMATE AMOUNT OF BLOOD LOSS. THERE WAS NO MACHINE ALARM. THE PT WAS HOSPITALIZED AND EXPIRED A FEW DAYS LATER. INFORMANT DOES NOT KNOW CAUSE OF DEATH. LOT IS UNKNOWN. A DHR WILL BE DONE ON THE 7 LOTS DELIVERED TO THIS FACILITY (3PR140, 3PR160, 3PR179, 3SR068, 3SR083, 4AR084, 4AR092). ALL COMBISETS DELIVERED TO THIS UNIT WERE SAP# 3-2922-7. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RCG COMBI SET BLOODLINE FJK REYNOSA MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death