BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2142498 · Received June 28, 2011

    Report

    Report Number
    6000001-2011-09117
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF NO FLOW WAS CONFIRMED. EXAMINATION OF THE TUBING AND THE BLADDER SHOWED NO SIGNS OF BLOCKAGE. DEVICE'S CAP WAS REMOVED AND FLOW WAS NOT READILY OBSERVED AT THE FLOW RESTRICTOR DESPITE ATTEMPTS OF FORCED PRIME. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. ADDITIONAL: A BATCH REVIEW HAS BEEN PERFORMED ANT 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 THERE WAS A NO FLOW THAT OCCURRED DURING FILLING. THE DEVICE WAS FILLED WITH 5% GLUCOSE. FORCE PRIMING WAS ATTEMPTED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. 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 11B009

    Patients

    Seq Age Sex Outcome Treatment
    1