BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2964945 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-04014
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS NOT AVAILABLE FOR EVLAUATION; HOWEVER THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DUE TO IT BEING REPORTED DURING TROUBLESHOOTING THAT THE CUSTOMER SWITCHED THE CASSETTE ONLY. THE CAUSE WAS DETERMINED TO BE USER ERROR/POOR ASEPTIC TECHNIQUE. PER BAXTER LABELING; THE AUTOMATED PD SET IS INTENDED FOR SINGLE USE ONLY. ADDITIONAL INFORMATION:A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERITONEAL DIALYSIS AN AUTOMATED PERITONEAL DIALYSIS 4 PRONG CASSETTE SET, SINGLE USE DEVICE, WAS REPORTED TO HAVE BEEN REUSED. THE HP WAS ADVISED TO ALWAYS START OVER WITH NEW SUPPLIES AND TO CALL GLOBAL TECHNICAL SERVICES FOR SUPPORT WHEN HE HAS ALARMS. THE HP STATED THAT HE HAD SPOKEN TO HIS NURSE ABOUT THIS AND WAS GIVEN ANTIBIOTICS AS A PREVENTATIVE. THE HP SAID HE HAS NOT HAD ANY ADVERSE EVENTS DUE TO THE CHANGING OUT OF SUPPLIES. NO ALLEGATIONS WERE MADE AGAINST ANY OTHER OF THE HP'S DIALYSIS PRODUCTS. THERE WAS A PATIENT INVOLVEMENT; HOWEVER THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68708 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12F21108

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE| DIANEAL SOLUTION