BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3943574 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23201
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). THE LOT 14A057 WAS MANUFACTURED BETWEEN JANUARY 26, 2013 ¿ JANUARY 28, 2013. A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. ONE ACTUAL UNIT WAS RECEIVED FOR EVALUATION. THE UNIT CONTAINED 105 ML OF FLUID IN ITS BLADDER. VISUAL INSPECTION ON THE UNIT (VIA THE NAKED EYE) SHOWED NO EVIDENCE OF FLOW AT THE DISTAL LUER WHEN THE LUER CAP WAS REMOVED. MICROSCOPIC INSPECTION OF THE FLOW RESTRICTOR REVEALED THE CAUSE OF THE PROBLEM WAS DUE TO MICRO AIR BUBBLES BLOCKING THE FLUID PATH INSIDE THE LUMEN OF THE GLASS CAPILLARY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A JAPANESE SMALL VOLUME INFUSOR DID NOT FLOW. THE DEVICE WAS FILLED WITH AN UNKNOWN SOLUTION USING THE BAXTER RECOMMENDED FILLING PROCEDURE, AND FLOW WAS INITIALLY CONFIRMED. BUT LATER, STILL PRIOR TO PATIENT CONNECTION, THE NURSE OBSERVED NO FLOW FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422739 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14A057

    Patients

    Seq Age Sex Outcome Treatment
    1