BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1932271 · Received December 17, 2010

    Report

    Report Number
    1423500-2010-07004
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT INFORMATION WAS UNKNOWN. 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 GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. GTS HAD THE PATIENT CLOSE THE CLAMPS AND CYCLE POWER TO CLEAR THE ERROR. THE PATIENT AND BAGS WERE CONNECTED AT THE TIME OF THE ERROR. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND THEY WOULD NEED TO START OVER USING NEW SUPPLIES. GTS THEN ADVISED THE PATIENT TO NOTIFY THEIR NURSE. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO STATED SHE DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THE LOT INFORMATION WAS UNKNOWN AND THE SAMPLE WAS NOT AVAILABLE. THE PATIENT STATED THAT SHE NOTIFIED HER NURSE WHO THOUGHT THE ERROR MAY HAVE BEEN CAUSED BY THE PATIENT PRESSING "GO" BEFORE CONNECTING, BUT THE PATIENT STATED THAT SHE DID NOT REMEMBER DOING THAT. THE PATIENT ADVISED THAT SHE HAD RESUMED THERAPY AND EVERYTHING WAS GOING WELL. NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)