BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2902137 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00526
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT IS CONFIRMED DUE TO THE USE ERROR DESCRIBED BY THE HOME PATIENT, WHO REPLACED THE CASSETTE BUT REUSED SOLUTION BAGS WHILE ATTEMPTING TO RESOLVE A LEAK. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON (B)(4) 2012 IN REGARDS TO A LEAK AND HE MENTIONED THAT HE FOUND OUT LATER IT WAS THE CASSETTE THAT WAS LEAKING. HE SAID THAT, THAT NIGHT HE HAD A LOT OF TROUBLE WITH CHECK LINES AND BAGS ALARMS AND CHANGED OUT ONLY THE CASSETTE 4 TIMES AND THEN WOULD START THE MACHINE BACK UP AGAIN. THE WRITER ADVISED HIM AGAINST REUSING SUPPLIES. HE SAID HE DID RECEIVE HIS NEW MACHINE AND NEEDED TO CONTACT HIS NURSE ABOUT PROGRAMMING IT. HE WAS JUST USING MANUAL SUPPLIES CURRENTLY UNTIL HE COULD HAVE HIS NURSE HELP HIM. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9027 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12E14089

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOME CHOICE