BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS GRAVITY SET

    MDR report key: 9717566 · Received February 17, 2020

    Report

    Report Number
    9616066-2020-00475
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Report Date
    January 28, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403234316
    PMA / PMN Number
    K820278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED: D.10. THE CUSTOMER¿S REPORT OF A GRAVITY TUBING LEAK AT THE INJECTION PORT WAS CONFIRMED. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. VISUAL INSPECTION OF THE ASSOCIATE SETS NOTED CLEAR LIQUID IN THE SET¿S DRIP CHAMBER AND ENTIRE LENGTH OF TUBING. NO ABNORMALITIES WERE OBSERVED. FUNCTIONAL AND PRESSURE TESTING RESULTED IN NO LEAKING. PHOTO PROVIDED BY THE CUSTOMER SHOWS LEAKING AT THE INJECTION PORT OF A GRAVITY TUBING. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM. ALTHOUGH REQUESTED, PATIENT INFORMATION NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 250ML BRAUN BAG, LOT: J9N180, EXP: 10/21, 0.9% NACL INJECTION; BD CATHETER . NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. ALTHOUGH REQUESTED, NO PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM. ALTHOUGH REQUESTED, PATIENT INFORMATION NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179113 ALARIS GRAVITY SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10796812 10885403234316

    Patients

    Seq Age Sex Outcome Treatment
    1 21 GAUGE NEEDLE,3ML SYRINGE, TD UNK