BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1932603 · Received December 19, 2010

    Report

    Report Number
    6000001-2010-06010
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    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. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A NO FLOW THAT OCCURRED WITH THE CLEARLINK DUO-VENT CONTINU-FLO SET. THE PATIENT WAS SET TO RECEIVE AN UNKNOWN ANTIBIOTIC WITH A 100 ML SECONDARY BAG. THE PRIMARY BAG WAS A 1000 ML BAG OF NORMAL SALINE. THE NURSE WAS USING A COLLEAGUE SINGLE CHANNEL PUMP WITH THIS SETUP. THE NURSE DID NOT SQUEEZE THE BAG TO INITIATE FLOW. THE NURSE DID NOT INVERT AND TAP THE CHECK VALVE TO PURGE THE AIR. PER THE CUSTOMER, THEY HAVE NEVER HEARD OF EITHER OF THESE TECHNIQUES. THE SECONDARY SET IS THE SET THAT DEMONSTRATED THE NO FLOW. THE DRIP CHAMBER WAS NOT FLOODED OR FULL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 100ML BAG OF AN UNK ANTIBIOTIC| 1000ML BAG OF NORMAL SALINE| COLLEAGUE SINGLE CHANNEL PUMP