BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1812656 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02808
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 18, 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 CAUSE OF THE REPORTED CHECK HEATER LINE ALARM IS THE CASSETTE DEFORMATION. THE ALARM WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE PATIENT STATED THAT AFTER AN ALARM, HE PULLED THE CASSETTE OUT AND THE PLASTIC WAS FOUND TO BE DEFORMED / BLOWN OUT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY NECESSARY SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT 6 CASSETTES WERE STUCK, AND WHEN THE HOME PATIENT (HP) PULLED THE CASSETTE OUT, IT WAS FOUND TO BE DEFORMED / BLOWN OUT. DURING A FOLLOW-UP WITH THE HP REGARDING THE REPORTED PROBLEM. THE HP STATED THAT HE HAD NO SAMPLES TO PROVIDE AND DID NOT RECALL THE LOT NUMBER. THE HP STATED THAT HE NOTICED LARGE AIR BUBBLES INSIDE THE CASSETTE, PRIOR TO USING THE CASSETTE. THE HP WAS ADVISED THAT HE SHOULD CONTACT THE NURSE AND TO CONTACT GLOBAL TECHNICAL SERVICES (GTS) FOR TROUBLESHOOTING ASSISTANCE WITH ANY OTHER ALARMS THAT HE MIGHT HAVE ENCOUNTERED. THE HP STATED THAT HE HAD NOT HAD ANY PROBLEMS SINCE RECEIVING THE NEW BOX OF CASSETTES WITH A DIFFERENT LOT. THE HP RESUMED THERAPY SUCCESSFULLY WITHOUT ANY COMPLICATIONS AND DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    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 55 YR