BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183501 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09968
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    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 IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AN OVERPRIME WAS NOT CONFIRMED IN THE LAB. NO ROOT CAUSE WAS DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THAT THE SOLUTION WAS COMING OUT OF THE END OF THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) PRESS STOP AND CLOSE THE CLAMP ON THE PATIENT LINE. THE TSR INSTRUCTED THE HP TO START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE