BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2132376 · Received June 17, 2011

    Report

    Report Number
    6000001-2011-07908
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 29, 2011
    Report Date
    May 30, 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 COMPLAINT INCIDENT FOR "NO FLOW/NON DELIVERY" AFTER FILLING WAS NOT CONFIRMED. THE EVALUATION SHOWED THE DEVICE FLOWED WITHOUT STOPPING OR DIFFICULTY BEFORE EMPTYING. 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. THE SAMPLE RECEIPT DATE HAS BEEN PROVIDED.

    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 WAS OBSERVED AFTER FILLING. NO FORCE PRIMING WAS ATTEMPTED. DUE TO REMOVING A NEEDLE, THERE MIGHT BE A HOLE AT THE FILLING PORT OR HOUSING. THE DEVICE WAS FILLED WITH SANDOSTATINE. 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 11A028

    Patients

    Seq Age Sex Outcome Treatment
    1