BEUDAMED
    FDA Adverse Event Injury Summary report: N

    B. BRAUN

    MDR report key: 1340066 · Received March 9, 2009

    Report

    Report Number
    MW5010251
    Event Type
    Injury
    Date Received
    March 9, 2009
    Date of Event
    February 18, 2009
    Report Date
    March 9, 2009
    Manufacturer
    B BRAUN MEDICAL INC
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OUR DIALYSIS UNIT PURCHASED NEW B. BRAUN DIALYSIS MACHINES LATE LAST YEAR. THEY WERE THE "NEWER" VERSION OF OUR OLDER MACHINES. THESE NEW MACHINES HAVE A FILTER TO IMPROVE WATER QUALITY USED IN DIALYSIS TREATMENT. THIS FILTER DECREASES BACTERIA AND PYROGENS TO PROVIDE A HIGHLY PURE DIALYSATE. WHEN WE PURCHASED THE MACHINES, NO TRAINING WAS DONE ON HOW THESE FILTERS MAY AFFECT OUR PATIENTS AND THEIR DIALYSIS TREATMENTS. WE WERE INSTRUCTED ON HOW TO CHANGE THEM OUT AND RESET THE DATA; THE FILTERS EXPIRE AFTER SO MANY TREATMENTS. AFTER WE HAD BEEN TRAINED ON THE MACHINES, WE PUT THEM INTO ROTATION ON THE DIALYSIS FLOOR. STAFF STARTED TO NOTICE THE PATIENTS WERE COMING OFF LIGHTER THAN THE DIALYSIS MACHINES HAD BEEN PROGRAMMED. THIS VARIED FROM 500CC TO 2 LITERS. WE IMMEDIATELY CONTACTED B. BRAUN REPS AND OUR BIOMED SUPPORT. WE DID NOT RECEIVE MUCH HELP FROM THE B. BRAUN SERVICE CENTER. IN FACT, WE WERE TOLD IT WAS OPERATOR ERROR WITH EACH EVENT. OUR DIALYSIS MDS HAD TO ADJUST PATIENT'S DRY WEIGHT AND ADJUSTED BP MEDS TO ENSURE SAFETY. FINALLY, B BRAUN INSTRUCTED US WE NEEDED TO PERFORM A "DECALCIFICATION" OF THE FILTER IN BETWEEN TREATMENT. THE REP PROCEEDED TO TELL US THAT ON PAGE 10-17 OF THE MANUAL, THERE WAS A "WARNING" BOX REGARDING UF RATES BEING UNCONTROLLED DUE TO CALCIFICATION OF THE FILTER. THIS IS THE ONLY BOX IN THE ENTIRE MANUAL DEDICATED TO THIS PROBLEM. FLUID REMOVAL IN DIALYSIS IS ONE OF MAIN COMPONENTS OF DIALYSIS. WE FELL THIS PROBLEM SHOULD HAVE BEEN MADE MORE WELL KNOWN UP FRONT. THIS WARNING NEEDS TO BE BIGGER AND MORE EDUCATION SHOULD OCCUR BEFORE PLACING PATIENTS ON IT. SINCE OUR CENTER LEARNED OF THIS NEEDED PROCEDURE, WE HAVE IMPLEMENTED DECALCIFYING BETWEEN TREATMENTS. HOWEVER, OUR PATIENTS STILL COME OFF LIGHTER THAN THE COMPUTER PROGRAMS. THE REP WAS BACK IN LAST WEEK AND HE REPORTED "OH, YOU GUYS ARE HAVING PROBLEMS WITH THAT TOO". OUR CENTER GETS THE IMPRESSION THAT THIS COMPANY KNEW ABOUT THIS PROBLEM AND DID NOTHING TO PREVENT IT FROM HARMING PATIENTS. THE REP'S STATEMENT OF OTHER CENTERS HAVING THIS PROBLEM MAKES US FEEL LIKE WE ARE NOT ALONE IN THIS PROBLEM. HOWEVER, MORE PATIENTS ARE BEING AFFECTED BY THIS AND IT NEEDS TO BE FIXED AT THE CORPORATE LEVEL. WE HAVE OUR DATA IN THE UNIT, TRENDING IT ACROSS ALMOST EVERY MACHINE AND THE PATIENTS IT HAS COME IN CONTACT WITH. WE HAVE BEEN DEALING WITH THIS PROBLEM SINCE THE MACHINES WERE OPERATIONAL IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B. BRAUN DIALOG + DIALYSIS MACHINE KDI B BRAUN MEDICAL INC DIALOG +

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability