BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2132898 · Received June 17, 2011

    Report

    Report Number
    6000001-2011-07970
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 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).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 BLUE WINGED CAP WAS NOTED TO BE SECURELY TIGHTENED ON THE WHITE LUER UPON SAMPLE RECEIPT. A LEAK TEST WAS SUBSEQUENTLY PERFORMED ON THE UNIT BY REFILLING THE RESERVOIR WITH RED COLOR WATER. AFTER PRIME WAS VERIFIED, THE BLUE WINGE CAP WAS SECURELY TIGHTENED ON THE WHITE LUER THEN THE DEVICE WAS BEING MONITORED FOR 24 HOURS. AFTER APPROXIMATELY THREE HOURS OF LEAK MONITORING PERIOD, LEAKAGE WAS READILY DETECTED AT THE CONNECTION OF THE BLUE WINGED CAP. THE ASSIGNABLE CAUSE WAS INSUFFICIENT BONDING. A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO EXCEPTIONS NOTED DURING THE MANUFACTURING OF THIS DEVICE. THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR IN WHICH THERE WAS A LEAK OBSERVED AT THE CONNECTION OF THE LUER ADAPTOR AND THE BLUE WINGED CAP. THE HOSPITAL WAS SURE THAT THE BLUE WINGED CAP WAS FASTENED. THE DEVICE WAS FILLED WITH 5-FLUOROUACIL AND NORMAL SALINE. 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 10J044

    Patients

    Seq Age Sex Outcome Treatment
    1