BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1912143 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06435
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 8, 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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF AN OVERPRIME - LEAK OUT OF PATIENT LINE. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE AND NO ROOT CAUSE HAS BEEN IDENTIFIED. 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. A BATCH REVIEW WAS NOT PERFORMED SINCE THE LOT INFORMATION WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL FOR A RELATED REPORT, THE HOME PATIENT (HP) STATED THAT SOMETIMES SOLUTION LEAKS OUT OF THE PATIENT LINE WHEN PRIMING. THE HP CONFIRMED THE LINE IS CHECKED FOR AIR PRIOR TO CONNECTION. THE HP CONFIRMED THE NURSE WAS AWARE OF THE SITUATION AND STATED THAT IT WAS OK. 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 82 YR