BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1901982 · Received November 18, 2010

    Report

    Report Number
    1423500-2010-05908
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 31, 2010
    Report Date
    October 31, 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)(6). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE COULD NOT BE DETERMINED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO WATCH FOR SIMILAR OCCURRENCE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DRAIN 3. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. GTS HAD THE PATIENT CYCLE POWER AND EXPLAINED THAT THERAPY HAD ENDED. GTS THEN EXPLAINED THE PATIENT WOULD NEED TO START OVER WITH NEW SUPPLIES OR FINISH THERAPY MANUALLY. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT REGARDING THIS REPORT. THE PATIENT STATED THAT HE DID NOT KEEP THE SAMPLE BECAUSE HE FIGURED OUT THAT THE ADAPTER TO THE TRANSFER SET WAS NOT SCREWED IN TIGHT ENOUGH. THE PATIENT STATED THAT THERE WAS SOME FLUID WHERE THE CONNECTION WAS, BUT NOT ANYWHERE ELSE, SO HE FIGURED OUT THAT THE CONNECTION WAS NOT TIGHT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 51 YR