BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 LEAD EXTENSION SET W/INTERLINK INJECTION SITE

    MDR report key: 2032832 · Received March 29, 2011

    Report

    Report Number
    6000001-2011-02322
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K915390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 3 FOR THE REPORTED ISSUE. DURING A FOLLOW CALL TO THE CUSTOMER ON (B)(6) 2011 THE UNIT MANAGER CONFIRMED THAT SHE RECEIVED THE SAMPLE RETURN KIT AND HAS PUT THE SAMPLES IN THE MAIL (TO RETURN TO BAXTER FOR EVALUATION). SHE REPORTED THAT SHE HAS SUBMITTED A FACILITY MED WATCH FOR EACH OF THE ALLEGED SEPARATIONS (3) WHICH CONTAIN ANY ADDITIONAL INFORMATION THAT SHE MAY HAVE HAD REGARDING THE INCIDENTS. FOLLOW UP INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED THE SAMPLE FOR THIS COMPLAINT, PRODUCT CODE 2N3341, LOT UNKNOWN. THE SAMPLE ARRIVED OUT OF THE POUCH USED. VISUAL INSPECTION SHOWED THAT THE SAMPLE WAS SEPARATED FROM THE OUTLET PORT OF THE BIFURCATED Y. CLOSER VISUAL INSPECTION OF THE SAMPLE UNDER A MICROSCOPE SHOWED THAT THE SEPARATIONS PROBABLY OCCURRED DUE TO THE LACK OF, OR NO SOLVENT BONDING ON THE TUBING ENDS OF THE RETURNED SAMPLES. THE REMAINING BOND JUNCTIONS OF THE SAMPLE WERE THEN INSPECTED FOR INTEGRITY. THE SAMPLE WAS USED WITH BLOOD. THE SAMPLE WAS VISUALLY INSPECTED, BUT NOT REMOVED FROM THE PLASTIC BAG, BECAUSE THE SAMPLE IS CONTAMINATED WITH BLOOD. DIMENSIONAL TEST, PRESSURE TEST AND FUNCTIONAL TEST COULD NOT BE DONE BECAUSE THE SAMPLE IS CONTAMINATED WITH BLOOD. A BATCH REVIEW FOR THE ACTUAL LOT COULD NOT BE DONE AS THE LOT NUMBER WAS NOT PROVIDED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOTS (R10G07016, R09O14055, R10K03133, R09K13143, R10J07045). NO DEVIATIONS WERE FOUND IN THE BATCH REVIEW. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(4) 2011 A BAXTER SALES REPRESENTATIVE CONTACTED CORPORATE PRODUCT SURVEILLANCE TO REPORT IN (B)(6) 2011 A CUSTOMER EXPERIENCED A SEPARATION THAT WHILE USING THE 3-LEAD EXTENSION SET. THE SET WAS IN USE ON A 7 HOUR OLD BABY WHO WAS ADMITTED FOR RESPIRATORY DISTRESS AND WAS PLETHORIC. AN INFUSION OF D10W WAS STARTED AT 9AM. THE NURSE CHECKED ON THE PATIENT AT 3PM AND EVERYTHING WAS FINE, BUT THEN CHECKED BACK AT 3:15PM AND THE TUBING SEPARATED AT THE Y-CONNECTOR NEAR THE INTERLINK SITE. THE AMOUNT OF BLOOD LOST WAS ESTIMATED TO BE 5-10CCS. THE BABY WAS DOING FINE. DURING A FOLLOWUP CALL TO THE CUSTOMER ON (B)(6) 2011, THE UNIT MANAGER REPORTED THERE WAS NO DECREASE IN HEMATOCRIT (NUMBERS NOT REPORTED). THE BABY REMAINED STABLE BECAUSE IT WAS ON A WARMER. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 LEAD EXTENSION SET W/INTERLINK INJECTION SITE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 7 HR Required Intervention D10W