BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2180211 · Received July 27, 2011

    Report

    Report Number
    6000001-2011-14872
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 1, 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: NO FLOW CONDITION NOT CONFIRMED. DEVICE'S CAP WAS REMOVED, AND FLOW WAS READILY OBSERVED AT THE LUER. FLOW CONTINUED WITHOUT STOPPING UNTIL THE SOLUTION WAS EMPTIED FROM THE BLADDER. NO SIGNS OF DEFECT WERE NOTED FROM THE SAMPLE. ADDITIONAL: A BATCH REVIEW WAS 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. THE DEVICE HAS BEEN REQUESTED BUT NOT YET RECEIVED AT BAXTER FOR EVALUATION. 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 (B)(4) TO REPORT AN INFUSOR IN WHICH NO FLOW WAS OBSERVED AFTER FILLING. THE DEVICE WAS FILLED WITH SALINE. FORCE PRIMING WAS ATTEMPTED, BUT THERE WAS NO FLOW. THERE WAS NO PATIENT INVOLVEMENT. THERE IS 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 11D088

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE