BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6494499 · Received April 14, 2017

    Report

    Report Number
    9616066-2017-00596
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    January 24, 2017
    Report Date
    March 17, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 100ML FRESENIUS KABI NDC 0338-0519-58, LOT 10KF7914, EXP 06/2018 INTRALIPID 20%; CLAVE NEEDLE-FREE CONNECTOR; CENTRAL LINE, GREEN SWAB CAP; THERAPY DATE (B)(6) 2017. THE CUSTOMER¿S REPORT OF THE TUBING WAS FOUND DISCONNECTED FROM THE PATIENT'S CENTRAL LINE WAS NOT CONFIRMED. THE SETS WERE VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. DURING INSPECTION IT WAS NOTED THAT THE DISTAL MALE LUER OF THE PRIMARY SET AND THE FEMALE LUER AND DISTAL MALE LUER OF THE CONCOMITANT EXTENSION SET HAD RESIDUE OF THE INTRALIPID EMULSION ON THEIR OUTSIDE SURFACES. THE MALE AND FEMALE LUERS OF BOTH SETS WERE INSPECTED UNDER MAGNIFICATION TO OBSERVE FOR ANY CRACKS, FRACTURES, OR STRESS MARKS. NO ISSUES WERE. WHITE LIQUID WAS OBSERVED INSIDE THE PRIMARY SET¿S DRIP CHAMBER AND INSIDE BOTH SETS TUBING. A GREEN SWAB CAP WAS ATTACHED TO BOTH OF THE PRIMARY SET¿S SMARTSITES. NO OTHER ANOMALIES WERE OBSERVED ON THE SET. FUNCTIONAL AND PRESSURE TESTING RESULTED IN THE SET FLOWING FREELY AND RAN WITH NO ISSUES OBSERVED. NO DISCONNECTIONS AT THE SET¿S LUER COMPONENTS WERE OBSERVED. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE MALE LOCK LEUR AND WAS FOUND TO BE WITHIN SPECIFICATION. THE ROOT CAUSE OF THE DISCONNECTED TUBING WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE TUBING WAS FOUND DISCONNECTED FROM THE PATIENT'S CENTRAL LINE." THE CUSTOMER STATED THAT THE DISCONNECTION OCCURRED DURING A TPN/ LIPIDS INFUSION. A BLOOD GLUCOSE LEVEL WAS DRAWN BECAUSE THE TPN HAD BEEN OFF FOR AN HOUR. LAB RESULTS WERE NOT PROVIDED AND THERE WAS NO REPORT OF ANY PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276546 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10933805

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Required Intervention 20128E,8100,8015