BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2202833 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10593
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    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 REPORT OF A USE ERROR WAS CONFIRMED AND THE CAUSE WAS IDENTIFIED AS THE PATIENT FAILING TO FOLLOW PROPER THERAPY STEP PROCEDURES. DURING TROUBLESHOOTING OF AN ALARM SITUATION CHECK SUPPLY LINE, PATIENT CHANGED OUT THE CASSETTE ONLY AND REUSED THE BAGS, DURING THERAPY. THE LABEL REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE ERROR IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS IN PROGRESS THROUGH CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    DURING ASSISTANCE FOR A PREVIOUS CHECK SUPPLY LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, THE HOME PATIENT (HP) STATED THAT THEY TRIED TO START OVER WITH A NEW CASSETTE, BUT THE HC STILL ALARMED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) SUGGESTED THEY START OVER WITH ALL NEW SUPPLIES. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM, THE HP STATED THEY DID TALK TO THEIR NURSE REGARDING THE PROBLEM. THE HP STATED THAT THEY FOUND WHAT HAD CAUSED THE ALARM. THE HP ALSO STATED WHEN THEY STARTED OVER WITH NEW SUPPLIES, THEY JUST CHANGED OUT THE CASSETTES BUT REUSED THE SAME BAGS, WHICH LED TO THE REPEAT OF THE ALARM. THE HP STATED THERAPY HAS BEEN CONTINUING FINE AND THEY HAVE NOT REPEATED THE SAME MISTAKE AGAIN. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE