BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2080558 · Received May 6, 2011

    Report

    Report Number
    6000001-2011-03768
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR IN WHICH A LEAK WAS OBSERVED AT THE FILLING PORT DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10F044

    Patients

    Seq Age Sex Outcome Treatment
    1