BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP

    MDR report key: 4397621 · Received January 3, 2015

    Report

    Report Number
    MW5040020
    Event Type
    Death
    Date Received
    January 3, 2015
    Report Date
    January 3, 2014
    Manufacturer
    BAXTER
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY BROTHER WAS DOING DIALYSIS AT HOME SUPPLIES WERE PROVIDED BY BAXTER HE GOT A BAD INFECTION WAS HOSPITALIZED INFECTION WAS IN THE ABDOMEN WHERE HE WAS DOING THE DIALYSIS THEY HAD TO TAKE BUT THERE HE WAS DOING THE TRANSFER AND PUT THE AREA FOR DIALYSIS IN HIS NECK, HIS INFARCTION WAS SO BAD HE DID NOT KNOW ANY OF HIS FAMILY HE WAS HOSPITALIZED ON (B)(6) 2013. I THEN RECEIVED AN URGENT RECALL LETTER FROM BAXTER DATED MAY 23, 2013 FOR A PRODUCT HE WAS USING "MINICAP PRODUCT CODE 5C4466P, LOT #GD893891 DUE TO INCOMPLETE SEAL WHICH MAY RESULT THE IODINE FROM DRYING OUT AND COULD CAUSE A SERIOUS INFECTION. HE REMAINED IN THE HOSPITAL FOR TWO MONTHS STRAIGHT WHEN HE WAS ABLE TO GO HOME HE CONTINUED TO GO IN AND OUT OF THE HOSPITAL UNTIL HE PASSED AWAY. I HAVE CALLED BAXTER AND THEY SAY THEY ARE GOING TO CALL ME BACK AND THEY HAVE NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196 MINICAP MINICAP KDJ BAXTER SC4466P GD893891

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H