BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4211806 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37937
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION WITH FLUID WITHIN ITS OVER POUCH. DURING VISUAL INSPECTION THE TUBING AT THE JUNCTION WITH THE DISTAL LUER LOCK WAS OBSERVED TO BE BROKEN CAUSING THE LEAK. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE BROKEN TUBING IS UNKNOWN. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INTERMATE LEAKED. THIS WAS NOTICED AFTER THE DEVICE WAS FILLED WITH 90 MG PAMIDRONATE IN 250 ML OF SODIUM CHLORIDE (BAXTER COMPOUNDED SOLUTION), WHILE DEVICE WAS BEING UNPACKED, AND BEFORE PATIENT USE. THE REPORTER STATED THAT UPON RECEIPT, THE BOX CONTAINING THE DEVICE WAS FOUND TO BE WET AND APPROXIMATELY 75% OF THE DEVICE¿S SOLUTION HAD LEAKED FROM AN UNKNOWN LOCATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692415 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14G025

    Patients

    Seq Age Sex Outcome Treatment
    1