BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1923751 · Received December 14, 2010

    Report

    Report Number
    1423500-2010-06862
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT INFORMATION WAS UNKNOWN. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE HOME CHOICE (HC) DURING THERAPY. GTS HAD THE HOME PATIENT (HP) TURN ON THE MACHINE. GTS CHECKED THE ALARM LOG, AND FOUND A SYSTEM ERROR 2240 FROM (B)(6) 2010. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. THE HP STATED HE WAS WOKEN UP BY THE ALARMS AND CLOSED EVERYTHING UP, DISCONNECTED FROM THE HC, AND DISCARDED THE SUPPLIES. THE HP COULD NOT REMEMBER IF THERE WAS A LEAK OR ANYTHING. GTS SUGGESTED THE HP CALL WHEN HE WAS HAVING THE ALARM SO BAXTER COULD TROUBLESHOOT. PRODUCT SURVEILLANCE CONTACTED THE HP AND THEY STATED THAT THEY DID NOT HAVE ANY IDEA WHAT MIGHT HAVE CAUSED THE ALARM. ALL THE SUPPLIES LOOKED OKAY AND HE DID NOT NOTE ANY DEFECTS. THE LOT NUMBER WAS UNKNOWN, AND NO SAMPLE WAS AVAILABLE. THE HP NOTIFIED HIS NURSE. THE HP WAS CONTINUING THERAPY WITHOUT COMPLICATIONS AND SAID HE WAS FEELING FINE. NO PATIENT INJURY OR MEDICAL INTERVENTION 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 73 YR