BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2121524 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07513
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 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 COMPLAINT FOR A CONNECTION ISSUE WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS USE ERROR, INCOMPLETE CONNECTION. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A USE ERROR; SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC). THE CARE GIVER (CG) STATED THAT THE HEATER BAG LINE CAME DISCONNECTED IN FILL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE CG TO START OVER WITH ALL NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP, CG STATED THAT THE HOME PATIENT (HP) HOOKED UP THE BAGS AND DID NOT CONNECT ONE OF THE BAGS TIGHT ENOUGH, WHICH CAUSED THE CONNECTION ISSUE. THE CONNECTION ISSUE CAUSED THE ALARM. HP WAS CONTINUING THERAPY WITHOUT ANY OTHER COMPLICATION. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    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 85 YR HOMECHOICE