BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL SECONDARY MED SET, LUERLOCKAND HANGER NO DISTAL CONNECTOR

    MDR report key: 1932636 · Received December 19, 2010

    Report

    Report Number
    6000001-2010-06028
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    March 29, 2010
    Report Date
    April 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. 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 QUALITY RELATIONS THAT A NO FLOW OCCURRED DURING A CHEMOTHERAPY INFUSION WITH THE CLEARLINK SECONDARY MEDICATION SET AND A CLEARLINK CONTINU-FLO SOLUTION SET. THE INFUSION WAS SET TO INFUSE 75ML AND THE PRIMARY WAS A KVO. THE PRIMARY SOLUTION WAS 250ML NS. THE SECONDARY SOLUTION WAS 250ML NS AND UNKNOWN CHEMOTHERAPY DRUG, IN AN UNKNOWN PLASTIC IV BAG. THE SECONDARY WAS DISCONNECTED AND RECONNECTED AND THEN FLOWED CORRECTLY. THE CHECK VALVE WAS INVERTED AND TAPPED AND THE SOLUTION BAG WAS SQUEEZED TO INITIATE FLOW. THE DRIP CHAMBER WAS NOT FULL/FLOODED AND THE NO FLOW IS OCCURRING AT THE LUER CONNECTION. THERE ARE NO SAMPLES AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL SECONDARY MED SET, LUERLOCKAND HANGER NO DISTAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE S09K17086R

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARLINK CONTINU-FLO SET, UNKNOWN IV CONTAINER| UNKNOWN CHEMOTHERAPY DRUG, NORMAL SALINE