BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1951808 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00237
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 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). THIS COMPLAINT FOR A CHECK HEATER LINE ALARM COULD NOT BE CONFIRMED IN THE LAB, BECAUSE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THE LOT NUMBER IS UNKNOWN, THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION, THE HEATER BAG SPIKE BECAME DISCONNECTED. THE ROOT CAUSE WAS NOT IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HC DEVICE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK HEATER LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY WHILE REFILLING THE HEATER BAG DURING FILL 1 OF 4, THE HOME PATIENT (HP) REVEALED THAT THE HEATER BAG CONNECTION CAME OUT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP END THERAPY, AND THE HP WOULD RE-SETUP THE HC MACHINE WITH NEW CASSETTE AND BAG. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE NURSE REGARDING THE HEATER BAG CONNECTION COMING OUT, IT WAS REVEALED THAT THE HP DID NOT REPORT THIS EVENT TO HER, AND NEITHER DID HE REPORT ANY SYMPTOMS OR DEFECTS ON THE SUPPLIES TO THE NURSE SINCE (B)(6) 2010. PER NURSE, HP IS CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    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 50 YR HC CYCLER