BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2043490 · Received April 7, 2011

    Report

    Report Number
    1423500-2011-04174
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM ERROR 2240 WAS IDENTIFIED DURING A REVIEW OF A RETURNED HOMECHOICE DEVICE. THERE WAS NO REPORT FOR THIS ALARM OR ALLEGATION OF A PRODUCT MALFUNCTION CALLED IN BY THE CUSTOMER, THEREFORE, THE SAMPLE WAS NOT REQUESTED. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE CAUSE WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER, THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE EVENT WAS FOUND DURING REVIEW OF THE HOME CHOICE (HC) 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. NO FURTHER INFORMATION IS AVAILABLE.

    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 53 YR HOMECHOICE