BEUDAMED
    FDA Adverse Event Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1915686 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06580
    Date Received
    December 6, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 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). ADDITIONAL INFORMATION: AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF SOLUTION FLOW BETWEEN BAGS AND THE PATIENT NOT CAPPING THE PATIENT LINE WHEN DISCONNECTING. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE LOT NUMBER IS UNKNOWN AT THIS TIME. THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING ASSISTANCE WITH ONE SUPPLY BAG DRAINED INTO THE SECOND SUPPLY BAG ON THE HOMECHOICE (HC) UNIT DURING USE. HOME PATIENT (HP) STATED THAT SHE WAS NOT SURE WHAT TO DO SO SHE DISCONNECTED AND CAPPED OFF THE TRANSFER SET BUT NOT THE PATIENT LINE ON THE HC. TSR ASSISTED WITH END OF THERAPY EARLY PROCEDURE. HP TO START OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR