BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1902023 · Received November 18, 2010

    Report

    Report Number
    1423500-2010-05916
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 30, 2010
    Report Date
    October 30, 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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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 PATIENT CONTACTED (B)(6) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. (B)(6) EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. (B)(6) HAD THE PATIENT CYCLE POWER AND ADVISED THE PATIENT TO START OVER USING NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT REGARDING THE REPORTED EVENT. THE PATIENT STATED SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THE PATIENT STATED THERE WERE NO DISCONNECTIONS, LOOSE CONNECTIONS, SEPARATIONS OR HOLES IN ANY OF THE SUPPLIES IN USE. THE PATIENT STATED HE DISCARDED THE SAMPLE AND DID NOT KNOW THE LOT NUMBER. THE PATIENT STATED SHE WAS ABLE RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THE PATIENT DID NOT NOTIFY THE NURSE OF THIS ISSUE, BUT WAS ADVISED TO DO SO. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR