BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENOUS BLOODLINE FOR FRES 2008; GAMBRO-A

    MDR report key: 316192 · Received February 13, 2001

    Report

    Report Number
    8030665-2001-00003
    Event Type
    Death
    Date Received
    February 13, 2001
    Date of Event
    January 11, 2001
    Report Date
    January 22, 2001
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED A DISCONNECT OF THE VENOUS BLOODLINE FROM THE FISTULA NEEDLE ABOUT ONE HOUR INTO THE TREATMENT. ESTIMATED BLOOD LOSS 1200 TO 1500CC. THE PT WAS GIVEN A TOTAL OF 1800 CC OF NORMAL SALINE AND OXYGEN WAS ADMINISTERED. THE PT STABILIZED AND WAS TRANSPORTED TO THE HOSPITAL ER. THE PT THEN WAS TRANSFERRED TO ANOTHER HOSP IN STABLE CONDITION WHERE THEIR PHYSICIAN WAS BASED. THE PT WAS ADMITTED TO THE SECOND HOSPITAL. THE PT WAS JUDGED TO BE STABLE. THE PLAN WAS TO GIVE THE PT A TRANSFUSION AND FURTHER DIALYSIS THE NEXT DAY. THE NEXT DAY THE PT EXPIRED DUE TO CARDIAC ARRHYTHMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5508 VENOUS BLOODLINE FOR FRES 2008; GAMBRO-A HEMODIALYSIS VENOUS BLOODLINE FKJ ERIKA DE REYNOSA NA 0KR148

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization 1. FMC 2008H DIALYSIS MACHINE.| 2. MEDISYSTEM 16G FISTULA NEEDLE.