BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1901214 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05856
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 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 WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DWELL 3/6 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. 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 THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR SE2240 ALARM (AIR IN THE SET) WHILE ON THE HOMECHOICE (HC) DEVICE DURING DWELL 3/6. THE TECHNICAL SERVICE REPRESENTATIVE HAD THE HOMEPATIENT (HP) CYCLE POWER AND EXPLAINED THAT SHE WOULD NEED TO START OVER WITH NEW SUPPLIES. THE HP WAS GOING TO CALL THE PERITONEAL DIALYSIS NURSE (PD) (RN) IN THE MORNING FOR THERAPY ADVICE AND JUST DISCONTINUE THERAPY FOR NOW AND DISCARDED THE SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S NURSE REGARDING THE SYSTEM ERROR. THE NURSE STATED THAT SHE JUST SAW THE PATIENT ON (B)(6) 2010 AND EVERYTHING WAS FINE. THE PATIENT HAS BEEN CONTINUING THERAPY. NO MEDICAL INTERVENTION OR PATIENT INJURY WAS ASSOCIATED WITH THIS REPORT.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1