BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2183316 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09916
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PARTICULATE MATTER FOUND IN THE TUBING WAS FIBRIN.THE CAUSE IS PHYSIOLOGICAL, RELATED TO CATHETER ISSUE. DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED THERE IS NO ALLEGATION OF BAXTER PRODUCT FOR THE REPORTED ISSUE, HENCE NO EVALUATION WILL BE PERFORMED.

    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 510K NUMBER CANNOT BE PROVIDED AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT PARTICULATE MATTER OCCURRED ON HOME CHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED THAT SHE HAD BROWN PIECES IN THE TUBING. THE HP STATED THAT SHE WAS NEW TO THE HOME CHOICE (HC) AND THE NURSE HAD SET IT UP FOR HER. THE HP WAS NOT WILLING TO PRESS ANY OF THE BUTTONS IN ORDER TO GET THE DRAIN VOLUME (DV). THE HP WILL DISCONNECT FROM THE HC AND LET THE NURSE DEAL WITH IT IN THE MORNING. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) WAS ABLE TO GET THE HP TO POWER THE HC OFF. THERE WAS PATIENT INVOLVEMENT. THERE WAS 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1