BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CONTINU-FLO SOLN SETW/CONTROL-A-FLO

    MDR report key: 1943116 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06497
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K940867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE THE REPORTED CONDITION OF NO FLOW WAS NOT CONFIRMED OR DUPLICATED AND AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER IS NOT KNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE; A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING DIFFICULTY PRIMING THE TUBING. THE TUBING ACTS AS IF THERE IS AN "AIR LOCK" AND THEN IT SUDDENLY FLOWS. THE CUSTOMER TRIED INVERTING AND TAPPING THE CHECK VALVE AND REGULATOR. THE REPORTED CONDITION OCCURRED WHILE INFUSING ERTAPENEM TO A PATIENT. THE CUSTOMER DID NOT SQUEEZE THE BAG TO INITIATE FLOW PER LABEL COPY. THE AREA OR COMPONENT ASSOCIATED WITH THE NO FLOW WAS THE ENTIRE TUBING. THE DRIP CHAMBER WAS NOT FLOODED OR FULL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE WAS A SMALL DELAY IN PATIENT THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO SOLN SETW/CONTROL-A-FLO SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 ERTAPENEM