BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141161 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08386
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS IDENTIFIED AND CONFIRMED IN THE LOGS OF THE RETURNED HOMECHOICE DEVICE. THE CAUSE WAS UNDETERMINED. A BATCH REVIEW FOR THE DISPOSABLE CASSETTE WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. 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).SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE SYSTEM ERROR OCCURRED ON (B)(6) 2011. A SE 2240 IS A NON-RECOVERABLE ALARM THAT OCCURS WHEN THE DEVICE HAS DETECTED AIR BEING DRAWN CONTINUOUSLY INTO THE DISPOSABLE. IT IS UNKNOWN IF THIS ALARM OCCURRED DURING PATIENT THERAPY; HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT FOR THIS ALARM CALLED IN BY THE CUSTOMER.

    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 61 YR HOMECHOICE