BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2119098 · Received June 9, 2011

    Report

    Report Number
    6000001-2011-07399
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 23, 2011
    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). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. ADDITIONAL: A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO EXCEPTIONS NOTED DURING THE MANUFACTURING OF THIS DEVICE.

    Description of Event or Problem · 1

    UNDERINFUSION WAS OBSERVED DURING THE PATIENT USE AT THE HOSPITAL. THE ACTUAL FLOW RATE WAS UNKNOWN BUT THE EXPECTED RATE WAS 40ML (MILLILITERS)/24HR (HOUR). THE TOTAL FILL VOLUME WAS 100ML: 0.2% ROPIVACAINE HYDROCHLORIDE HYDRATE THE TEMPERATURE AND THE HEIGHT OF THE RESTRICTOR WERE UNKNOWN. PCM 2.0ML WAS USED WITHOUT REMOVING SHIPPING TAB OUT. THEREFORE, TOTAL 4 ML SHOULD'VE BEEN INFUSED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY AND MEDICAL INTERVENTION. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10N022

    Patients

    Seq Age Sex Outcome Treatment
    1