BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1891968 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05407
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 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 PROBLEM WAS RESOLVED OVER THE PHONE WITH THE CUSTOMER BY THE BAXTER TECHNICAL SERVICE REPRESENTATIVE. THE PATIENT WAS INSTRUCTED TO RESTART THEIR THERAPY WITH NEW DISPOSABLE SUPPLIES. THIS WAS AN INCIDENT INVOLVING A USER ERROR DURING THERAPY AND THERE WAS NO ALLEGATION AGAINST THE BAXTER PRODUCT; THEREFORE THE SAMPLE WILL NOT BE REQUESTED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DID NOT CONNECT PRIOR TO INITIATING THERAPY. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS PATIENTS IN THE PROPER SEQUENCE OF STEPS TO PERFORM BEFORE PATIENT CAN PRESS "GO" TO START THE THERAPY. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. THIS INCIDENT WAS RESOLVED OVER THE PHONE USING THE CURRENT LABEL COPY. 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).

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. (B)(4) EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE AND HAD THE CAREGIVER CYCLE POWER TO CLEAR THE ALARM. (B)(4) ADVISED THE CAREGIVER TO START OVER USING NEW SUPPLIES. THERAPY HAD BEEN STARTED PRIOR TO THE PATIENT CONNECTING. UPON CONNECTION, THE HC ALARMED WITH THE SYSTEM ERROR 2240. PRODUCT SURVEILLANCE SPOKE WITH THE PATIENT'S DIALYSIS NURSE. THE NURSE STATED THE SHE WAS NOT AWARE OF THE EVENT BUT AS FAR AS SHE KNEW, THE PATIENT HAD CONTINUED THERAPY WITHOUT COMPLICATION. NO INJURY OR MEDICAL INTERVENTION WAS 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 77 YR