BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022752 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03348
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 23, 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 REPORT OF A CONNECTION ISSUE WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USER ERROR - INCOMPLETE CONNECTION. 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. 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.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED THE HEATER LINE CAME OUT OF THE HEATER BAG AND FELL ON THE FLOOR. THE HOME PATIENT (HP) STATED SHE THEN RECONNECTED THE LINE TO THE HEATER BAG. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT SHE WILL NOW NEED TO END THE THERAPY AND START OVER WITH ALL NEW SUPPLIES. THE TSR THEN ASSISTED THE HP TO CYCLE POWER OFF/ON, END THE THERAPY AND THEN START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE HEATER LINE DISCONNECTING AND HITTING THE FLOOR. PER THE HP, SHE REALIZED THERE WAS FLUID ON THE FLOOR AND THAT SHE DID NOT TURN THE LUER CONNECTOR ALL THE WAY. THE HP STATED SHE DISCARDED THE SUPPLIES AND THE LOT NUMBER WAS NOT KNOWN. THE HP STATED SHE CLEANED UP THE FLUID AND STARTED OVER WITH NEW SUPPLIES WITHOUT ANY PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 HOMECHOICE DEVICE