BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 200, 48 PACK,50125

    MDR report key: 1840489 · Received September 21, 2010

    Report

    Report Number
    6000001-2010-03403
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    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 OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR SV 200 DEVICE WAS MISSING A CAP BEFORE USE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 10C061

    Patients

    Seq Age Sex Outcome Treatment
    1