BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 6441552 · Received March 28, 2017

    Report

    Report Number
    9616066-2017-00490
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 6, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPB
    PMA / PMN Number
    K801614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A LEAK AT THE CONNECTION BETWEEN THE PRIMARY TUBING AND THE FILTER TUBING SETS WAS NOT CONFIRMED. BOTH SETS WERE VISUALLY INSPECTED (INCLUDING USE OF MICROSCOPE) AND NO EVIDENCE OF DAMAGE OR ANOMALIES WAS OBSERVED. FUNCTIONAL AND PRESSURE TESTING RESULTED IN NO LEAKS OR OTHER ANOMALIES ON ANY PART OF THE SETS AND THEIR COMPONENTS. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): A 100ML FRESENIUS KABI BAG NDC 0338-0519-58, LOT 10KF7914, EXP 06/2018, INTRALIPID 20%, THERAPY DATE (B)(6) 2017. GTIN/UDI NUMBER FOR ITEM 20127E, LOT 16105693 IS (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE INFUSING LIPIDS AT AN UNSPECIFIED RATE A LEAK WAS NOTED AT THE PRIMARY TUBING AND THE FILTER CONNECTION. THE LIPIDS WERE HELD FOR 72 HRS. PER CLINICIAN. THE PATIENT WAS AFEBRILE AFTER 72 HRS. WITH NO REPORT OF PATIENT HARM. THE TUBING WAS IN USE FOR 20HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223516 ALARIS EXTENSION SET SET, EXTENSION, INTRAVASCULAR FPB CAREFUSION 20127E 16105693

    Patients

    Seq Age Sex Outcome Treatment
    1 8015,2426-0500,8100, TD (B)(6) 2017