BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3697988 · Received March 25, 2014

    Report

    Report Number
    1416980-2014-09781
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED. ONE USED SAMPLE WAS RECEIVED WITH APPROXIMATELY 190 ML OF FLUID IN THE BLADDER. VISUAL INSPECTION SHOWS NO SIGNS OF OCCLUSION OR BLOCKAGE THAT COULD HAVE CAUSED THE REPORTED PROBLEM. AFTER THE LUER CAP WAS REMOVED FROM THE DISTAL LUER, CONTINUOUS FLOW WAS IMMEDIATELY OBSERVED AT THE DISTAL LUER. FLOW WAS ALSO OBSERVED WHEN THE PCM BUTTON WAS PRESSED. THE SAMPLE WAS WORKING WITHIN SPECIFICATION. INITIAL EVALUATION DID NOT CONFIRM THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A JAPANESE BASAL/BOLUS LARGE VOLUME INFUSOR EXPERIENCED A NO FLOW. THIS WAS OBSERVED DURING INFUSION OF AN UNKNOWN MEDICATION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, 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
    175028 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12H025

    Patients

    Seq Age Sex Outcome Treatment
    1