BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3092355 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11249
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FRN
    PMA / PMN Number
    K880733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. DURING VISUAL INSPECTION OF THE SAMPLE, THE ANTI-SIPHON INJECTION SITE WAS IDENTIFIED TO BE MISSING. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CAUSE OF THE ANTI-SIPHON INJECTION SITE BEING MISSING COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANTI-SOPHON EXTENSION SET WAS MISSING AN ANTI-SIPHON INJECTION SITE. THIS WAS IDENTIFIED AFTER THE USER ATTEMPTED TO DISCONNECT THE SET FROM THE AIR-ELIMINATING IV EXTENSION SET AFTER A TOTAL PARENTERAL NUTRITION INFUSION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195100 ACCESS PUMP, INFUSION FRN BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN AIR-ELIMINATING IV EXTENSION SET| UNKNOWN TOTAL PARENTERAL NUTRITION