BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL NON-DEHP SOL SET 10 DPM .22FILTER 102" Y@6 W/2PC LL

    MDR report key: 1940967 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06317
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED DUE TO BLOOD CONTAMINATION. SINCE THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A CLEARLINK SOLUTION ADMINISTRATION SET WITH 0.22 MICRON FILTER THAT DEVELOPED A SPLIT MIDWAY DOWN THE TUBING. THIS INCIDENT RESULTED IN THE PATIENT'S CENTRAL LINE BACKING UP AND BLOOD LEAKING ONTO THE FLOOR. THIS ALSO RESULTED IN LOSS OF BLOOD FOR THE PATIENT AND BLOOD EXPOSURE TO THE STAFF. THE CUSTOMER REPORTED THAT THIS HAD BEEN A SPORADIC PROBLEM UP UNTIL THE LAST WEEK. THE THREE (3) INCIDENTS OCCURRED ON THREE (3) SEPARATE PATIENTS WITH THREE (3) DIFFERENT NURSES. THE CUSTOMER HAS ALSO DISCUSSED THE PROCEDURE OF PREPARING THE TUBING WITH THE NURSES TO ENSURE THAT IT IS NOT A "PROCESS" FAILURE. THE INCIDENTS OCCURRED DURING USE ON PATIENT, AND PER THE INITIAL REPORT, THERE WAS A PATIENT INJURY. THIS IS REPORT 1 OF 3 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL NON-DEHP SOL SET 10 DPM .22FILTER 102" Y@6 W/2PC LL SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10G26099

    Patients

    Seq Age Sex Outcome Treatment
    1