BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192146 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10291
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 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 COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. A LABELING REVIEW WAS NOT COMPLETED BECAUSE NO USE ERROR WAS SUSPECTED. 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 RENQ-CAPA-(B)(4).

    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 IS BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL. THE HOME PATIENT (HP) HAD TURNED THE HC OFF AND WAS AT THE END OF THERAPY. GTS ADVISED THE HP TO CONTACT THE NURSE. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE HP WHO SAID HE NOTIFIED HIS NURSE OF THE ALARM. THE HP SAID HE DID A MANUAL EXCHANGE AND THEN RESUMED THERAPY ON THE CYCLER SUCCESSFULLY THE NEXT NIGHT. 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 69 YR HOMECHOICE