BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 100, 48 PACK,50125

    MDR report key: 1973270 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00520
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 5, 2011
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: PER THE CUSTOMER'S INITIAL REPORT, THE DEVICE IS AVAILABLE FOR EVALUATION BY BAXTER. ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO RETRIEVE THE SAMPLE AND/OR ADDITIONAL INFORMATION. BAXTER WILL CONTINUE TO ATTEMPT TO CONTACT THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: A BATCH REVIEW WAS CONDUCTED WHICH FOUND ALL CRITERIA TO SPECIFICATIONS. THE CAUSE OF THE EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE/INFORMATION: PER THE CUSTOMER, THE DEVICE WILL NOT BE RETURNED TO BAXTER FOR EVALUATION; THEREFORE, THE REPORTED CONDITION OF "BROKEN TUBING" IS NOT CONFIRMED. SHOULD THE SAMPLE 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 HEALTHCARE THAT ONE (1) CE INTERMATE SV DEVICE WAS OBSERVED WITH THE END OF THE TUBING BROKEN OFF WHEN OPENING THE PACKAGING IT WAS SHIPPED IN. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Description of Event or Problem · 1

    THIS IS NOT REPORT 1 OF 2 AS STATED IN THE INITIAL MEDWATCH. THE CUSTOMER REPORTED 1 SAMPLE WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE SV 100, 48 PACK,50125 PUMP, INFUSION FRN 10K070

    Patients

    Seq Age Sex Outcome Treatment
    1