BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1962230 · Received January 17, 2011

    Report

    Report Number
    1423500-2011-00711
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR (SE) 2240 ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. 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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) TO REPORT A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 4 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CYCLE POWER TO CLEAR THE ALARM AND EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE HP CONFIRMED HE DID NOT SEE AN OBVIOUS CAUSE OF THE ALARM. THE HP STATED HE WOULD FINISH THERAPY WITH MANUALS AND CONTACT HIS NURSE REGARDING THE INCIDENT. THE TSR REVIEWED PROPER PROCEDURES WITH THE HP. ON (B)(4) 2010 PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER (CG) WHO VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS, OR PRODUCT DEFECTS NOTED. THE CG CONFIRMED NO ADVERSE EVENT RESULTED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE APD SYSTEM(5C4471R) REFURBISHED