BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV167,24 PACK

    MDR report key: 1779914 · Received August 2, 2010

    Report

    Report Number
    6000001-2010-02314
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE IS NOT AVAILABLE TO BAXTER FOR EVALUATION.

    Description of Event or Problem · 1

    BAXTER SALES DIRECTOR (BSD) SENT A MESSAGE TO CORPORATE PRODUCT SURVEILLANCE'S EMAILBOX (B)(6) 2010 TO RELAY CUSTOMER REPORT RECEIVED ON THE SAME DAY FOR ONE (1) INTERMATE, IN WHICH THE RESERVOIR BROKE AT THE END OF A PATIENT INFUSION ON AN UNKNOWN DATE, STATED AS POSSIBLY (B)(6) 2010. PER THE CUSTOMER, " HE WAS INFUSING FINE, WENT TO DISCONNECT AND FLUSH AT END OF INFUSION AND BALLOON INSIDE INTERMATE WAS BROKEN AND THERE WAS FLUID IN THE INTERMATE. I ASKED HIM IF IT LOOKED LIKE THE PLASTIC PIECE INSIDE WAS POKING THRU THE SIDE OF THE RUBBER AND HE SAID YES." 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 CE INTERMATE LV167,24 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10D088

    Patients

    Seq Age Sex Outcome Treatment
    1