BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 200, 48 PACK,50125

    MDR report key: 2021673 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01927
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) INTERMATE SV 200 DEVICE WAS OBSERVED LEAKING THROUGH THE FILL PORT DURING FILLING. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 320MG OF TOBRAMYCIN. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE SV 200, 48 PACK,50125 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10M081

    Patients

    Seq Age Sex Outcome Treatment
    1 TOBRAMYCIN