BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2122382 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07542
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 24, 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET) WAS IDENTIFIED DURING A REVIEW OF THE DEVICE ALARM LOGS OF A RETURNED HOMECHOICE (HC) DEVICE. THIS REPORT WAS NOT CONFIRMED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER. BASED ON THE INFORMATION OBTAINED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. A BATCH REVIEW WAS NOT PERFORMED BECAUSE LOT INFORMATION WAS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. 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 31 YR HOMECHOICE PRO