BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3250601 · Received July 26, 2013

    Report

    Report Number
    1416980-2013-19917
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPB
    PMA / PMN Number
    K113227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: SIX SAMPLES WERE RETURNED FOR EVALUATION. THE SAMPLES WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED. NO NONCONFORMANCES WERE FOUND. THE PRODUCTS OPERATED WITHIN SPECIFICATION AND THE REPORTED CONDITION WAS NOT CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. TWO ADDITIONAL, USED DEVICES OF THE SAME LOT WERE ALSO RECEIVED. VISUAL INSPECTION IDENTIFIED BROWN SPOTS ON THE FILTER OF ONE UNIT. THE DEVICES WERE FUNCTIONALLY TESTED WITH NO DEFECTS IDENTIFIED. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION FOR ONE OF THREE DEVICES. RESULT AND CONCLUSION CODES WILL BE UPDATED, FOR THE DEVICE FOR WHICH THE PROBLEM WAS CONFIRMED. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK EXTENSION SET HAD A DISCOLORED FILTER. THIS ISSUE WAS DISCOVERED DURING INFUSION OF TOTAL PERITONEAL NUTRITION (TPN). THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349823 ACCESS FILTER, INFUSION LINE FPB BAXTER HEALTHCARE - AIBONITO UR12J23032

    Patients

    Seq Age Sex Outcome Treatment
    1