BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® SYRINGE MODULE SET

    MDR report key: 8001554 · Received October 24, 2018

    Report

    Report Number
    9616066-2018-02037
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 3, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403233920
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORT OF A LEAK WAS CONFIRMED. FUNCTIONAL TESTING SHOWED THAT FLUID WAS LEAKING FROM THE ENGAGEMENT BETWEEN THE OUTLET PORT OF THE FILTER AND THE MICROBORE TUBING COMPONENT. FURTHER INSPECTION SHOWED THAT THE TUBING WAS NOT FULLY BONDED TO ITS MATED FILTER COMPONENT. THE ROOT CAUSE OF THE LEAK WAS A MANUFACTURING ASSEMBLY ISSUE OF INSUFFICIENT SOLVENT APPLICATION AT THE ENGAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DURING A FENTANYL AND DOPAMINE INFUSION, A LEAK WAS NOTED BELOW BOTH 0.2 MICRON FILTERS ON THE EXTENSION SETS. IT WAS REPORTED BY THE CLINICIAN THAT BOTH SETS WERE NEW WHEN THE LEAK OCCURRED. THERE WAS NO REPORT OF PATIENT HARM. THE EVENT OCCURRED IN PICU.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8015; 10014916; (2)MZ1000-07; (2)SPM TUBING; (2)8110; (2) NON BD 12ML SYRINGE WITH A 3ML LABEL, LOT 180930-010, EXP (B)(6) 2018, 0.45% SODIUM CHLORIDE FLUSH; THERAPY DATE (B)(6) 2018. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING A FENTANYL AND DOPAMINE INFUSION, A LEAK WAS NOTED BELOW BOTH 0.2 MICRON FILTERS ON THE EXTENSION SETS. IT WAS REPORTED BY THE CLINICIAN THAT BOTH SETS WERE NEW WHEN THE LEAK OCCURRED. THERE WAS NO REPORT OF PATIENT HARM. THE EVENT OCCURRED IN PICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838874 ALARIS® SYRINGE MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10014916 18057691 10885403233920

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR