BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192833 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10318
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) ALARM DURING THE INITIAL DRAIN WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. 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).

    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 THE INITIAL DRAIN ON THE HOME CHOICE (HC). THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE MESSAGE TO THE HOME PATIENT (HP) AND INSTRUCTED HER TO CYCLE THE HC. THE TSR INFORMED THE HP TO START OVER USING NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING A SYSTEM ERROR 2240 ALARM. THE HP STATED THEY WERE ABLE TO CLEAR THE ALARM AND CONTINUED THERAPY WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE PD RN, THE HP WAS DOING FINE ON THE CYCLER. NO FURTHER INFORMATION WAS GIVEN. THERE WAS PATIENT INVOLVEMENT.

    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 54 YR HOMECHOICE