BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1930733 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06961
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 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 IS FOR A CHECK PATIENT LINE ALARM AND WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE PATIENT STATED THAT THERE IS AIR IN THE PATIENT LINE. FROM THE DATA WITHIN THE COMPLAINT INFORMATION THE ROOT CAUSE WAS NOT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) A CHECK PATIENT LINE ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING INITIAL DRAIN. THE DRAIN VOLUME (DV) EQUALED 3ML. THE LAST FILL VOLUME (LFV) EQUALED 2200ML. (B)(4) HAD THE HOME PATIENT (HP) CLOSE AND OPEN THE TRANSFER SET 3 TIMES, MOVE THE CLAMP, RUB THE LINE, PULL UP ON THE LINES, CHECK THE LINES FOR FIBRIN AND AIR, AND THEN PRESS GO. THE HP WAS NOT DRAINING AT ALL. (B)(4) HAD THE HP CLOSE AND OPEN THE TRANSFER SET AND CHECK THE LINE FOR AIR AGAIN. THE HP NOW SEES AIR IN THE PATIENT LINE. (B)(4) ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES, MAKING SURE THAT THE PATIENT LINE WAS FULLY PRIMED BEFORE CONNECTING HERSELF. (B)(4) THEN WALKED THE HP THROUGH THE ENDING THERAPY EARLY PROCEDURE. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 80 YR PD CYCLER