BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1880109 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04769
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 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). THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, BAXTER CANNOT DETERMINE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A CHECK PATIENT LINE ALARM WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE, THEREFORE, THE CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERRORS IDENTIFIED IN THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A CHECK PATIENT LINE ALARM ON THE HOMECHOICE (HC) MACHINE DURING THE INITIAL DRAIN. THE HOME PATIENT (HP) STATED THAT THERE IS AIR IN HIS PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2010, AND THE PATIENT STATED THERE WERE NO HOLES OR LEAKS IN THE CASSETTE. THE PATIENT DID NOT NOTICE ANY DEFECTS IN THE SUPPLIES. THE PATIENT DISCARDED AND RESUMED THERAPY WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 90 YR