BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA

    MDR report key: 462789 · Received May 23, 2003

    Report

    Report Number
    462789
    Event Type
    Malfunction
    Date Received
    May 23, 2003
    Date of Event
    January 1, 2003
    Report Date
    January 1, 2003
    Manufacturer
    GAMBRO [RENAL PRODUCTS]
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE ICU DUE TO AN ASPIRIN OVERDOSE. THEY WERE ORDERED TO RECEIVE CVVHDF (CONTINUOUS VENO/VENO HEMODIALYSIS FILTRATION). THE RENAL FELLOW PLACED THE CATHETER, AND THE DIALYSIS NURSE PRIMED THE SET WITH SALINE SOLUTION. THE NURSE THEN ATTEMPTED TO LUER LOCK THE ARTERIAL LINE OF THE PRIMSA SET TO THE CATHETER. THE LUER LOCK KEPT TURNING AND WOULD NOT LOCK. THREE DIFFERENT SETS OF TUBING WERE USED AND THE CATHETER WAS CHANGED, BUT THE NURSE CONTINUED TO EXPERIENCE THE PROBLEM OF THE LUER LOCK NOT SECURING. FINALLY, THE TUBING WAS SECURED WITH TAPE AND THE NURSE REMAINED AT THE PT'S BEDSIDE TO ENSURE THE INTEGRITY OF THE LINE. THERE WAS NO SEQUELAE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA BLOOD LINES FJK GAMBRO [RENAL PRODUCTS] * 02G1778E
    2 PRISMA BLOOD LINES FJK GAMBRO (RENAL PRODUCTS) * 02G0265E
    3 HEMO-CATH DOUBLE LUMEN CATHETER MSD MEDICAL COMPONENTS, INC. * M249650

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other DIALYSIS, 2003| MEDCOMP CATHETER,