BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2151047 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08708
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 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 (SE) 2240 (AIR IN SET) OCCURRED DURING I-DRAIN WAS NOT CONFIRMED; HOWEVER PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE CAUSED BY THE PATIENT NOT CONNECTED WHEN THERAPY INITIATED. THE CAUSE WAS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SPECIFIC PRODUCT CODE FOR THE HOMECHOICE AUTOMATED PD SET WITH CASSETTE IS UNKNOWN; THEREFORE, D4 IS UNKNOWN. THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. PER THE INITIAL REPORT, THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CLOSE ALL THE CLAMPS AND TRANSFER SET, AND CYCLE THE POWER OFF AND ON. THE HC THEN HAD A SYSTEM ERROR 2367. THE TSR HAD THE HP CYCLE THE POWER AND PRESS GO TO START PROMPT. THE TSR EXPLAINED THE ALARMS AND THE HP STATED HE HAD NOT CONNECTED AND PRESSED GO. THE HP THEN CONNECTED WHICH CAUSE THE SYSTEM ERROR 2240. THE TSR EXPLAINED TO DISCARD ALL THE SUPPLIES AND TO REPORT THE ALARM TO THE PERITONEAL DIALYSIS (PD) NURSE (RN) THE NEXT MORNING. THE HP WOULD FINISH THE NIGHT'S THERAPY MANUALLY. THE PD RN CONTACTED BAXTER (B)(4) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE PD RN, HE WAS NOT AWARE OF THE ALARM. THE PD RN STATED THERE WAS NO MEDICAL FOLLOW UP AND THE HP WAS CURRENTLY USING THE CYCLER FOR THERAPY 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 78 YR HOMECHOICE