BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2180041 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09754
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 2, 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. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A USE ERROR - FAILED TO FOLLOW THERAPY STEPS WAS CONFIRMED BASED ON CAREGIVER (CG) STATING THAT THEY DID NOT USE A FLEXI CAP ON THE PA LINE WHEN THE HOME PATIENT (HP) DISCONNECTED ONLY THE MINI CAP. THE CAUSE WAS USE ERROR. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS FOR USE ERROR - CAREGIVER(CG) DID NOT USE FLEXI CAP ON PATIENT LINE AFTER DISCONNECTING. A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DISPLAY. THIS EVENT OCCURRED DURING USE PATIENT CONNECTED IN FILL 6/6. CG STATED THE HOME PATIENT (HP) DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE CG IF THE HP USED A FLEXI CAP ON THE PATIENT LINE. CG STATED NO, JUST THE MINI CAP ON HER. TSR EXPLAINED HE WILL ASSIST THE CG WITH ENDING THE THERAPY SINCE THE HP DISCONNECTED. 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