BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141727 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08414
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 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). DEVICE WAS REQUESTED BUT WAS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED AND THE ROOT CAUSE WAS UNDETERMINED. THE LOT NUMBER WAS NOT AVAILABLE THEREFORE A BATCH REVIEW WAS NOT BE PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING AN ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING FILL 1. GTS REVIEWED THE ALARM LOG AND A SYSTEM ERROR 2240 WAS FOUND. GTS EXPLAINED THE ALARM IS INDICATIVE OF AIR IN THE LINE AND EXPLAINED PROPER PROCEDURES. GTS HAD THE HOME PATIENT (HP) CYCLE POWER ON THE MACHINE AND RECEIVED A SYSTEM ERROR 2367 ENDING THE THERAPY. THE HP OPTED TO COMPLETE THERAPY MANUALLY. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO SAID HE NOTIFIED HIS NURSE OF THE ALARM. THE HP SAID THAT HE COMPLETED THERAPY THAT NIGHT USING MANUAL SUPPLIES. THE PATIENT WAS INVOLVED BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION 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 54 YR HOMECHOICE