BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® SECONDARY ADMINISTRATION SET

    MDR report key: 5024783 · Received August 24, 2015

    Report

    Report Number
    9616066-2015-01037
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 31, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BAXTER HEALTHCARE CORPORATION, 100ML BAG 0.9% SODIUM CHLORIDE INJECTION USP, LOT P333005, EXP OCT 2016; BAXTER HEALTHCARE CORPORATION, 250ML BAG 0.9% SODIUM CHLORIDE INJECTION USP, LOT C976720, EXP OCT 2016; THERAPY DATE : (B)(6) 2015. . THE CUSTOMER¿S REPORT OF FLUID LEAKAGE AT THE CONNECTION SITE BETWEEN A TEXIUM SECONDARY SET AND A (NON-CAREFUSION) PRIMARY SET WAS CONFIRMED. FUNCTIONAL TESTING WAS PERFORMED. DURING PRIMING AND GRAVITY INFUSION, THERE WAS NO LEAKING OBSERVED FROM ANYWHERE ALONG EITHER SET. GRAVITY INFUSION WAS PERFORMED WITH AND WITHOUT THE SMARTSITE CONNECTION, AND LEAKAGE WAS NOT OBSERVED IN EITHER CASE. DURING PRESSURE TESTING WHEN THE SMARTSITE VALVE WAS NOT IN PLACE, A SLIGHT LEAK WAS OBSERVED TO BE COMING FROM WHERE THE SECONDARY TEXIUM MALE LUER WAS CONNECTED TO THE PRIMARY (NON-CAREFUSION) SET. THE ROOT CAUSE FOR THE LEAKAGE WAS DETERMINED TO BE INCOMPATIBILITY BETWEEN THE SECONDARY TEXIUM SET AND THE NON-CAREFUSION PRIMARY SET. NO LEAKAGE OCCURRED DURING USE WITH A SMARTSITE NEEDLE-FREE VALVE AS PER THE TEXIUM DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT OR NEAR THE TEXIUM CONNECTOR OF A SECONDARY SET DURING INFUSION. THERE IS NO REPORT OF PATIENT OR PROVIDER HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT OR NEAR THE TEXIUM CONNECTOR OF A SECONDARY SET DURING AN INFUSION OF CYCLOPHOSPHAMIDE 1,188 MG IN NORMAL SALINE. AFTER THE LEAK WAS DISCOVERED, A CONNECTOR WAS ADDED AND THE INFUSION COMPLETED WITHOUT INCIDENT. THERE IS NO REPORT OF PATIENT OR PROVIDER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557686 ALARIS® SECONDARY ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10013364T

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR