BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2181900 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09875
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED FOR USE ERROR. THE ROOT CAUSE WAS NOT IDENTIFIED. 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER. THEREFORE THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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 (B)(4) REGARDING ASSISTANCE WITH A LOW DRAIN VOLUME ALARM DURING DRAIN 3 OF 4 ON THE HOMECHOICE MACHINE (HC). THE HP STATED THEY ARE DRAINING TO THE BATHROOM AND THEY USE ONE DRAIN LINE EXTENSION. THE HP STATED THAT THE CAREGIVER CHANGES THE DRAIN LINE EXTENSION EVERY 3-4 USES. THE TSR EXPLAINED THAT THE EXTENSION SHOULD BE CHANGED DAILY. THE TSR ADVISED THE HP TO CHANGE THE DRAIN LINE EXTENSION DAILY TO AVOID POSSIBLE ALARMS. THE CAREGIVER (CG) WAS CONTACTED ON (B)(6) 2011. THE CG STATED THE HOME PATIENT IS CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HOMECHOICE