BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2230207 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-21919
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 30 ML OF SOLUTION IN THE RESERVOIR. THE TUBING WAS CLAMPED. WHEN THE TUBING WAS UNCLAMPED, LEAKAGE WAS DETECTED AT THE LUER POST NEAR THE DELIVERY TUBING. THE REPORTED CONDITION OF LEAK WAS CONFIRMED. VISUAL EXAMINATION OF THE LUER POST SHOWED EVIDENCE OF CRACK WHERE THE LEAKAGE OCCURRED. BASED ON THE EVALUATION, BROKEN/CRACKED LUER NEAR THE BASE OF THE STEM IS DUE TO STRESS FROM THE PACKAGING DESIGN. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE SAMPLE. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH TIER I (B)(4).

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INTERMATE LEAKED AT THE DELIVERY TUBING NEAR THE PATIENT CONNECTOR AFTER FILLING. THE DEVICE WAS FILLED WITH 50-MILLILITERS SOLUTION OF 0.9% SALINE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11C071

    Patients

    Seq Age Sex Outcome Treatment
    1