BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT

    MDR report key: 1973244 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00492
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 12, 2010
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. THE BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE (CPS) CONCERNING A CONTINU-FLO PRIMARY SET THAT WOULD NOT BACK PRIME SALINE INTO A SECONDARY SET DURING PRIMING. THERE WAS NO PATIENT INJURY, ADVERSE REACTION OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE, BAXTER SECONDARY SET