BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2081985 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05635
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED BASED ON INFORMATION PROVIDED BY THE PATIENT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE IN REGARD TO THIS ISSUE. THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE CAUSE OF THE USE ERROR, THEREFORE THE ROOT CAUSE IS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 5. THE HOME PATIENT (HP) STATED ONLY SUPPLY BAG HAS SOLUTION AND HEATER AND FINAL BAGS ARE EMPTY. THE HP ALSO STATED THAT EARLY ON HE HAD MISTAKENLY CONNECTED FINAL BAG TO SUPPLY LINE AND SUPPLY BAG TO FINAL LINE- HE HAD THEN SWITCHED THE BAGS BACK OVER TO CORRECT LINES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER ON MACHINE TO END OF THERAPY AND THEN GO TO MANUAL DRAIN TO DRAIN OUT. THE TSR EXPLAINED THE ALARM AND POSSIBLE CAUSES AND ASSISTED THE HP TO END THERAPY AND DRAIN MANUALLY. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 HOME CHOICE