BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241902 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11997
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    March 25, 2011
    Report Date
    August 23, 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). SYSTEM ERROR 2240 (AIR IN LINE) WAS CONFIRMED AS IT WAS IDENTIFIED IN THE ALARM LOGS OF THE RETURNED DEVICE. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. BAXTER HAS FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE SYSTEM ERROR OCCURRED ON (B)(6) 2011. IT IS UNKNOWN IF THIS ALARM OCCURRED DURING PATIENT THERAPY, HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 HOMECHOICE