BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1760946 · Received July 19, 2010

    Report

    Report Number
    1423500-2010-01539
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS DISCARDED AND NO COMPANION SAMPLES WERE AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A RELOAD SET ALARM AND A LEAKING CASSETTE. THE COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ALARM WAS DETERMINED TO BE DUE TO THE LEAKING CASSETTE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT AN ALARM ON THE HOMECHOICE (HC) MACHINE DURING SELF-TESTING. WHILE TROUBLESHOOTING, THE HOME PATIENT (HP) STATED THE SET WAS LEAKING. THE HP WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE SPOKE WITH THE HP ON (B)(6) 2010. THE HP STATED SHE THREW OUT THE ACTUAL CASSETTE. NO COMPANION SAMPLES WERE AVAILABLE AND THE LOT NUMBER WAS UNKNOWN. THE HP STATED THE LEAK WAS FROM THE ACTUAL CASSETTE AND SHE DID NOT SEE ANY TEARS, SO SHE THOUGHT IT MUST HAVE JUST BEEN A PIN-HOLE. THE HP WAS NOT CONNECTED AT THE TIME THE LEAK WAS FOUND. THE HP HAS BEEN DOING FINE AND CONTINUING THERAPY ON THE CYCLER AS USUAL.

    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 50 YR