BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2233911 · Received September 6, 2011

    Report

    Report Number
    1423500-2011-11691
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 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) DURING DRAIN 1 OF 7 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE LOT NUMBER IS UNKNOWN AT THIS TIME. THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR 2240 (AIR IN SET) DURING DRAIN 1 OF 7 ON THE HOME CHOICE (HC) MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WAS UNABLE TO DETERMINE WHY THE SYSTEM ERROR OCCURRED. THE TSR HAD THE HOME PATIENT (HP) CLOSE ALL THE CLAMPS TO BAGS, PATIENT LINE AND TRANSFER SET, CYCLE THE POWER OFF/ON TWICE , PRESSED GO TO START AND THE HC WAS AT LOAD THE SET, REMOVE THE CASSETTE. THE TSR ADVISED THE HP TO DISPOSE OF CURRENT SUPPLIES AND START OVER WITH ALL NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE PDRN, THE HP HAD NOT FOLLOWED UP WITH THEM REGARDING THE ALARM. THE PDRN STATED THE HP WAS CURRENTLY USING THE CYCLER FOR THERAPY. 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 76 YR HOMECHOICE