BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1984387 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01767
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A LEAK WAS NOT CONFIRMED, AND NO ROOT CAUSE WAS DETERMINED, BECAUSE THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS NOT PERFORMED SINCE NO LOT NUMBER WAS AVAILABLE. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT THE HOMECHOICE MACHINE DOOR WAS DAMP DURING THE SET-UP STEP INDICATING A LEAK SOMEWHERE IN THE PERITONEAL DIALYSIS THERAPY SET-UP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CAREGIVER (CG) WIPE OFF THE HC DOOR WITH A DRY CLOTH, THEN INSERT A NEW CASSETTE, CLOSE THE DOOR, CLOSE THE CLAMPS AND PRESS GO. THE TSR ASSISTED THE CG TO COMPLETE SETUP UP TO PRIMING. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW-UP WITH THE CG, IT WAS FOUND THAT SHE HAD HOOKED EVERYTHING UP AND THERE WAS "WATER" UNDER THE HC MACHINE. THE CG STATED THAT NO BAGS WERE LEAKING AND ALL OF THE CONNECTIONS AND SUPPLIES WERE FINE. THE CG STATED THAT HER HUSBAND WAS ABLE TO CONTINUE WITH THERAPY. NO MEDICAL INTERVENTION OR PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE CYCLER