BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2250161 · Received September 15, 2011

    Report

    Report Number
    1423500-2011-12270
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 26, 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 IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 ALARM DUE TO A USE ERROR. COMPLAINT IS CONFIRMED AND THE ASSIGNABLE CAUSE, TRANSFER SET BECAME DISCONNECTED BECAUSE TRANSFER SET CONNECTION NOT TIGHT ENOUGH, CAUSING AN ALARM SITUATION SYSTEM ERROR 2240. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION REPORTED BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WAS NOT CONDUCTED. THE LABEL REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE ERROR IN THIS INCIDENT. 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 HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING FILL. THE HP STATED THEIR TRANSFER SET BECAME DISCONNECTED, THE HP STATED HIS WIFE DID NOT CONNECT THE TRANSFER SET TIGHT ENOUGH. THE ALARM OCCURRED WHILE THE HP WAS DISCONNECTED, SO THE HP CYCLED POWER TWICE TO CLEAR THE ALARM, THEN CONNECTED AND STARTED THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INFORMED THE HP TO NEVER RESTART THERAPY WITH HIS OLD SUPPLIES AND RECOMMENDED TO CALL BAXTER TO TROUBLESHOOT THE ALARM. THE TSR ASSISTED THE HP WITH ENDING THERAPY AND RECOMMENDED CONTACTING THEIR NURSE. A FOLLOW UP WAS DONE VIA PHONE CALL. THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) STATED THAT THEY JUST TALKED TO THE PATIENT REGARDING THE REPORTED PROBLEM. THE PD RN STATED THEY WENT OVER THERAPY WITH THE PATIENT AND RE-EXPLAINED THAT THEY CANNOT REUSE THE SAME SUPPLIES WHEN TRYING TO RESTART THERAPY. THE PD RN STATED THE PATIENT WAS EXAMINED AND THEY ARE OKAY. THEY STATED THAT THE PATIENT'S THERAPY IS BACK TO NORMAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 67 YR HOMECHOICE