BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 200, 48 PACK,50125

    MDR report key: 1984217 · Received February 10, 2011

    Report

    Report Number
    6000001-2011-00842
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED AND CONFIRMED THE REPORTED CONDITION OF A RESERVOIR RUPTURE. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH IDC-CAPA-(B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) HAT ONE (1) CE INTERMATE SV 200 DEVICE WAS OBSERVED LEAKING DURING FILLING. ACCORDING TO THE REPORT, THE DEVICE WAS BEING FILLED WITH NORMAL SALINE WHEN THE LEAK WAS OBSERVED. 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 10B076

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE