BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183475 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09961
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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 SYSTEM ERROR 2240 (AIR IN SET) WAS CONFIRMED. THE CAUSE WAS DUE TO A USE ERROR RESULTING IN AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE SUPPLY BAG CAME DISCONNECTED FROM THE SUPPLY LINE. THE PATIENT STATED THAT SHE DID NOT TIGHTEN THE CONNECTION ALL THE WAY ON THE SOLUTION BAG, SO THAT IS WHY SHE GOT THE ALARM. THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. A LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN THE SET) DURING DWELL 1 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICES REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO CYCLE THE POWER. THE TSR ADVISED THE HP TO DISCONNECT AND RESTART THE SETUP WITH ALL NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HP STATED THAT SHE DID NOT TIGHTEN THE CONNECTION ALL THE WAY ON THE SOLUTION BAG. THE HP RESUMED THERAPY STARTING OVER WITH NEW SUPPLIES AND CONTACTED HER NURSE A FEW DAYS LATER REGARDING THE ALARM. THERE WAS PATIENT INVOLVEMENT. 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 83 YR HOMECHOICE