BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3760332 · Received April 20, 2014

    Report

    Report Number
    1416980-2014-12745
    Event Type
    Malfunction
    Date Received
    April 20, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE IS NOT AVAILABLE FOR EVALUATION, THOUGH A PHOTOGRAPH HAS BEEN PROVIDED AND WILL BE EVALUATED. A BATCH REVIEW WILL BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. EVALUATION INFORMATION: A PHOTOGRAPHIC INSPECTION IDENTIFIED THAT THERE WAS FLUID INSIDE OF THE RESERVOIR. FURTHER EVALUATION COULD NOT BE COMPLETED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE IDENTIFIED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED NO FLOW/NON-DELIVERY DURING USE OF THE INFUSOR ELASTOMERIC DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. IT IS UNKNOWN WHAT SOLUTION WAS INTENDED TO BE INFUSED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239164 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13G001

    Patients

    Seq Age Sex Outcome Treatment
    1