BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1896129 · Received November 10, 2010

    Report

    Report Number
    1423500-2010-05570
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A CHECK LINES AND BAGS ALARM WAS NOT CONFIRMED. THE USED SAMPLE WAS NOT PROVIDED TO BAXTER FOR EVALUATION. A BATCH REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. BASED ON INFORMATION IN THE COMPLAINT, THE CAUSE OF THE ALARM WAS THAT THE HOME PATIENT REPORTEDLY DROPPED THE SUPPLY BAG CAUSING IT TO COME UNDONE. CURRENT LABELING WAS REVIEWED AND WAS FOUND TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS COMPLAINT. 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).THE SAMPLE IS NOT AVAILABLE, THEREFORE, BAXTER CANNOT DETERMINE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A CHECK LINES AND BAGS ALARM ON THE HOMECHOICE (HC) MACHINE DURING FILL 3 OF 3. THE CAREGIVER (CG) STATED THAT THE HOME PATIENT (HP) DROPPED THE SUPPLY BAG AND IT CAME UNDONE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED THE HP AND CG TO END THERAPY. PRODUCT SURVEILLANCE CONTACTED THE HP'S CG ON (B)(6) 2010. ACCORDING TO THE CG THE PATIENT ACCIDENTALLY DROPPED THE BAG. THERE WERE NO DEFECTS IN THE SUPPLIES. THE PATIENT HAS RESUMED THERAPY WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR