BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2171767 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09293
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 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 DEVICE WAS REQUESTED BUT WAS NOT AVAILABLE. THE LOT NUMBER WAS NOT AVAILABLE THEREFORE A BATCH REVIEW WILL NOT BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THE COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED AS THE SAMPLE WAS NOT AVAILABLE AND THE ROOT CAUSE WAS UNDETERMINED. A LABELING REVIEW WAS NOT PERFORMED AS NO USE ERROR WAS SUSPECTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM AND THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL. GTS ASSISTED THE HOME PATIENT (HP) TO CLEAR THE ALARM BY CYCLING POWER ON THE HC AND ASSISTED THE HP WITH ENDING THERAPY. GTS EXPLAINED THE ALARM INDICATED AIR ENTERED THE SETUP, AND REVIEWED PROPER PROCEDURES. GTS ADVISED THE HP TO CONTACT THE NURSE. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE HP, WHO SAID SHE NOTIFIED HER NURSE. THE HP ALSO REPORTED SHE USED MANUAL SUPPLIES THAT NIGHT, AND THEN CONTINUED ON THE CYCLE THE NEXT NIGHT WITHOUT COMPLICATIONS. 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 59 YR HOMECHOICE