BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1963056 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00739
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    November 29, 2010
    Report Date
    December 27, 2010
    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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET) IDENTIFIED DURING A REVIEW OF THE DEVICE ALARM LOGS OF A RETURNED HOMECHOICE (HC) DEVICE. THE REPORTED CONDITION 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).

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    DURING AN INITIAL ASSESSMENT OF A HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED A 2240 ALARM (INDICATING AIR HAS ENTERED THE CASSETTE). THIS ALARM WAS IDENTIFIED DURING A REVIEW OF THE DEVICE ALARM LOGS; THERE WAS NO REPORT FOR THIS ALARM CALLED IN BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HOMECHOICE APD SYSTEM (B)(4) REFURBISHED