BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2161068 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-08998
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 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) OCCURRED DURING THE INITIAL DRAIN COULD NOT BE CONFIRMED DUE TO LACK OF SAMPLE. HOWEVER, BASED ON INVESTIGATION INFORMATION, THE CAUSE WAS DETERMINED TO BE USE ERROR- THE EXTENSION LINE WAS CONNECTED AFTER PRIME WAS COMPLETE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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 AND THE LOT NUMBER IS UNKNOWN. 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 THE HOME CHOICE (HC) SYSTEM ERROR (SE) 2240 (AIR IN THE SET), DURING THE INITIAL DRAIN. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THAT THE EXTENSION LINE NEEDED TO BE ADDED PRIOR TO PRIMING. THE HOME PATIENT (HP) ADDED TWO EXTENSION LINES AFTER THE PRIME TO THE PATIENT LINE. THE TSR INSTRUCTED THE HP TO CYCLE THE POWER TWICE TO THE DISPLAY PRESS GO TO START PROMPT. THE HP WOULD START WITH NEW SUPPLIES. BAXTER (B)(4) CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) ON (B)(6) 2011. THE PD RN STATED SHE WAS AWARE OF THE ALARM. PS ASKED THE PD RN IF THE HP IS AWARE OF THE PROPER SET UP PROCEDURES. THE PD RN STATED SHE WOULD ADDRESS THAT WITH THE HP. THE PD RN STATED THE HP WAS CURRENTLY USING THE CYCLER WITHOUT ANY PROBLEMS. PS CONTACTED THE CAREGIVER (CG) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE CG STATED THE HP DISCARDED THE SUPPLIES. THE CG STATED THE HP STARTED OVER WITH NEW SUPPLIES AND RESUMED THERAPY WITHOUT ANY PROBLEMS. 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 HOMECHOICE