BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1881244 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04872
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 2, 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). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT 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

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A CHECK PATIENT LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DISPLAY DURING THE INITIAL DRAIN. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE HOME PATIENT (HP) STATED THE TUBING ON THE PATIENT LINE WAS DISCOLORED. THE HP STATED THAT IT LOOKED GRAYISH BLACK. THE HP ENDED THERAPY, WOULD START OVER WITH NEW SUPPLIES AND WOULD CALL THE NURSE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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