BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1862683 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04252
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 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). THIS REPORT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE, THEREFORE, THE CAUSE WAS UNDETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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 IS NOT AVAILABLE FOR EVALUATION AS IT HAS BEEN DISCARDED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WILL NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A LOW DRAIN VOLUME ALARM WITH THE HOMECHOICE MACHINE DURING THE INITIAL DRAIN CYCLE. THE HOME PATIENT (HP) STATES THAT THE PATIENT LINE LOOKS LIKE IT'S HALF AIR HALF FLUID. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH ENDING THERAPY AND STARTING OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(4) 2010 REGARDING THE AIR IN LINE. THE PATIENT STATED THAT THERE WAS AIR AND FLUID IN THE LINE. THE PATIENT WAS TOLD TO EMPTY THE BAGS AND START OVER WITH NEW SUPPLIES. THE PATIENT STATED THAT THERE HAVE BEEN NO ISSUES SINCE THIS EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 74 YR