BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1914829 · Received December 4, 2010

    Report

    Report Number
    1423500-2010-06536
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    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). THE SAMPLE IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FROM A HOME PATIENT FOR OVERPRIME. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE AND BATCH REVIEW WAS NOT PERFORMED SINCE LOT NUMBER INFORMATION WAS NOT AVAILABLE. NO USE ERROR WAS SUSPECTED THEREFORE NO LABEL REVIEW WAS REQUIRED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED (B)(4) REGARDING AN OVER-PRIME THAT OCCURRED ON THE HOME CHOICE (HC) UNIT AT PRIME. THE CG STATED THAT A LITTLE WATER CAME OUT OF THE PATIENT LINE IN PRIME. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED TO THE CG THAT IT WAS OK; THE CAP WAS STILL ON THE PATIENT LINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 88 YR (B)(4) 1.5% LO/CAL UB 2L/2L (B)(4) 1.5%