BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1912791 · Received December 2, 2010

    Report

    Report Number
    1423500-2010-06456
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 7, 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 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A CHECK YOUR POSITION ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING FILL 1 OF 3. GTS INSTRUCTED THE HP WITH TROUBLESHOOTING STEPS. THE HP STATED THAT THERE WAS AIR IN THE PATIENT LINE. GTS RECOMMENDED THAT THE HP END THERAPY AND START OVER WITH NEW SUPPLIES. GTS THEN ASSISTED THE HP WITH ENDING THERAPY. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE NURSE (RN) WHO STATED, SHE WAS NOT AWARE OF ANY REPORTS OF AIR IN THE LINE FROM THE HP; THEREFORE, COULD NOT ADVISE ON WHAT MAY HAVE CAUSED THE AIR IN THE LINE. THE RN STATED, THE HP HAS NOT HAD ANY COMPLAINTS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR