BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOR

    MDR report key: 3903448 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20975
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K011317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. 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 FOR LOT NUMBER 13M021 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND THE PRODUCT MET RELEASE CRITERIA. THE DEVICE WAS NOT RETURNED, THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE CAUSE IS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME MULTIRATE INFUSOR OVERINFUSED A PATIENT. THE INFUSION ENDED FOUR HOURS AND FIFTEEN MINUTES EARLIER THAN THE EXPECTED 24 HOUR INFUSION TIME. THE DEVICE WAS FILLED WITH 80MG OF SODIUM CHLORIDE AND 20MG OF MIDAZOLAM. AS A RESULT OF THE OVERINFUSION, THE PATIENT EXPERIENCED PROLONGED APNEA AND UNCONSCIOUSNESS. TREATMENT AND OUTCOME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379898 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13M021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 80MG OF SODIUM CHLORIDE AND 20MG OF MIDAZOLAM