BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IL NUTRIFLO Y TYPE SOLUTION SET

    MDR report key: 2040241 · Received April 5, 2011

    Report

    Report Number
    6000001-2011-02582
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON EVALUATION, IT WAS DETERMINED THAT THE LEAK OCCURRED IN THE PORT OF THE FK INTRALIPID SET AND NOT THE BAXTER SET. THE SAMPLE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED TO BAXTER (B)(4) AN INTERLINK SYSTEM NUTRI-FLO Y-TYPE SOLUTION SET IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, AN INFANT IN THE NICU (MATERNAL CHILD DEPARTMENT) WAS RECEIVING TPN AND LIPIDS THROUGH THIS SOLUTION SET VIA A CENTRAL CATHETER. LIPIDS WERE NOTED TO BE LEAKING JUST BELOW DRIP CHAMBER WHERE TUBING CONNECTS. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. 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 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN INTERLINK SYSTEM NUTRI-FLO Y-TYPE SOLUTION SET IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, AN INFANT IN THE NICU (MATERNAL CHILD DEPARTMENT) WAS RECEIVING TPN AND LIPIDS THROUGH THIS SOLUTION SET VIA A CENTRAL CATHETER. LIPIDS WERE NOTED TO BE LEAKING JUST BELOW DRIP CHAMBER WHERE TUBING CONNECTS. THE CONDITION OCCURRED DURING PATIENT USE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IL NUTRIFLO Y TYPE SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE ST11A023

    Patients

    Seq Age Sex Outcome Treatment
    1 TPN, LIPIDS, CENTRAL CATHETER