BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 FT. EXTENSION SET, EASY LOCK CONNECTOR

    MDR report key: 377577 · Received February 13, 2002

    Report

    Report Number
    1423500-2002-00195
    Event Type
    Injury
    Date Received
    February 13, 2002
    Date of Event
    February 1, 2002
    Report Date
    February 1, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME PT (HP) SPOKE WITH BAXTER'S QUALITY ASSURANCE DEPT REGARDING AN ALLEGED LEAKY CONNECTOR FROM A PT EXTENSION LINE. REPORTEDLY, WHEN HP WAS SETTING UP THEIR SUPPLIES, PRIOR TO PRIME, HP CONNECTED TWO PT EXTENSION LINES TO THE PT LINE OF THEIR HOMECHOICE SET. HP MADE SURE THAT ALL CONNECTIONS WERE TIGHT, AND ADVANCED INTO PRIME. THE PRIMED SETUP SUCCESSFULLY WITHOUT ANY ALARMS, SO HP CONNECTED THEMSELVES TO THE SETUP AND BEGAN THEIR THERAPY. IN FILL 1 HP NOTICED FLUID LEAKING AT THE CONNECTION BETWEEN THE TWO PT EXTENSION LINES. HP IMMEDIATELY CLOSED THEIR TRANSFER SET, CLAMPED EVERYTHING OFF AND ENDED TREATMENT EARLY, IN ORDER TO COMPLETE THEIR THERAPY THEY SET UP WITH NEW SUPPLIES. THREE DAYS LATER HP REPORTED TO THEIR RN THAT THEIR EFFLUENT WAS CLOUDY. HP'S RN TOOK A CULTURE WHICH REVEALED STAPHYLOCOCCUS SPECIES (COAGULASE NEGATIVE). HP WAS INSTRUCTED TO ADMINISTER 1 GRAM OF CEFAZOLIN, INTRAPERITONEAL, DAILY FOR THE NEXT 10 DAYS ALONG WITH 40MG OF TOBRAMYCIN, INTRAPERITONEAL, DAILY FOR 2 DAYS. REPORTEDLY, HP HAS RECOVERED FROM THE INFECTION, NO HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12 FT. EXTENSION SET, EASY LOCK CONNECTOR APD 12 FT. EXTENSION LINE KDJ BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R AUTOMATED PD SET W/CASSETTE 4-PRONG.| HOMECHOICE AUTOMATED PD SYSTEM, HOMECHOICE