BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192147 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10292
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 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). THE COMPLAINT FOR USE ERROR OF A DRAIN LINE SUBMERGED IN THE WASTE RECEPTACLE WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING A CALL TO GLOBAL TECHNICAL SERVICE (GTS) FOR AN ALARM, A CARE GIVER (CG) FOUND THAT THE DRAIN LINE HAD FALLEN INTO THE DRAIN FLUID IN THE BUCKET. GTS HAD THE CG PULL THE LINE UP SO THAT IT WAS NOT TOUCHING THE FLUID AND PRESS GO ON THE HOMECHOICE TO RESTART FILL. THE ALARM CLEARED. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE NURSE, WHO SAID THE HOME PATIENT (HP) HAD NOTIFIED HER OF THE INCIDENT AND THEY HAD DISCUSSED THE ISSUE. THE NURSE SAID THE HP WAS DOING FINE, AND HAD NOT EXPERIENCED ANY COMPLICATIONS. PS ADVISED THE NURSE TO REMIND PATIENTS TO CHECK THE DRAIN LINE AND ENSURE IT IS NOT SUBMERGED. NO SERIOUS 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 70 YR HOMECHOICE