BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1905164 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-06108
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 29, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE OF 2 EMDRS. THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A DISCONNECTION OF A SUPPLY BAG WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE WAS NOT IDENTIFIED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP WITH THE NURSE, IT WAS FOUND THAT THEY USE A FIVE PRONG SET UP AND SOME OF THE SPIKES HAD COME OUT AND CAUSED THE LEAK. THE NURSE DID NOT RECALL ANYTHING REGARDING A DRAIN MANIFOLD, BUT STATED THAT THEY USE THE SOLUTION BAGS AND THEN USE THOSE AS DRAIN BAGS. THE NURSE WAS NOT REALLY SURE WHAT IT MEANT BY THE DRAIN MANIFOLD WAS LEAKING. THIS IS ALL THE INFORMATION THAT WAS ABLE TO BE OBTAINED FROM THE NURSE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT THE DRAIN MANIFOLD HAD BECOME SEPARATED AND LEAKED SOLUTION. THE CLINICAL EDUCATOR, WHO RECEIVED THE INITIAL REPORT, BELIEVED THE CAUSE WAS A USE ERROR BECAUSE THE NURSE WHO SET UP THE SUPPLIES MAY NOT HAVE HAD EXPERIENCE SETTING UP PERITONEAL DIALYSIS THERAPY. NO FURTHER INFORMATION WAS AVAILABLE. DURING A FOLLOW UP WITH THE NURSE MANAGER REGARDING THE REPORTED EVENT, IT WAS REVEALED THAT THE SEPARATION TOOK PLACE DURING PATIENT TRANSPORT AND ANOTHER TIME DURING PATIENT USE. THE NURSE STATED THE SPIKES SEPARATED FROM THE SOLUTION BAG.

    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