BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1971162 · Received January 26, 2011

    Report

    Report Number
    1423500-2011-01049
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED. THE DEVICE EVALUATION IS EXPECTED, BUT NOT COMPLETED YET. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR (SE) 2240/2367, THIS SITUATION OCCURRED DURING DWELL 1. THE HOME PATIENT (HP) CYCLED POWER. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY AND ADVISED THE USE OF NEW DISPOSABLES. THE TSR INSTRUCTED THE HP TO NOTIFY THE REGISTERED NURSE (RN). NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP, THE CARE GIVER (CG) STATED THAT THE HP DID NOT DISCONNECT AT ANYTIME DURING THERAPY AND THE CG DID NOT NOTICE ANYTHING UNUSUAL WITH THE SET UP. THE CG STATED THEY TALKED TO THE PD NURSE ABOUT THE ALARM. THE CG STATED THE HP RESUMED THERAPY THE FOLLOWING DAY WITH MANUALS WITHOUT ANY PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 H10K01079

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE CYCLER