BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SECONDARY SET

    MDR report key: 5946424 · Received September 13, 2016

    Report

    Report Number
    9616066-2016-01209
    Event Type
    Malfunction
    Date Received
    September 13, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 22, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K053049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A LEAK FROM A TEXIUM SECONDARY SET WAS NOT CONFIRMED. NO DAMAGE OR ANOMALIES WERE NOTED ON VISUAL INSPECTION. NO ABNORMALITIES NOTED ON MICROSCOPIC INSPECTION OF THE SECONDARY DISTAL TEXIUM LUER . FUNCTIONAL AND PRESSURE TESTING FOUND NO LEAKS. THE ROOT CAUSE OF THE CUSTOMER'S REPORT OF A LEAK FROM A TEXIUM SECONDARY SET WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BAXTER 500ML BAG OF 0.9% NACL INJECTION NDC 0338-0049-03, LOT Y203794, EXP SEP 2017; BAXTER 100ML BAG OF 0.9% NACL INJECTION NDC 0338-0049-48, LOT P350132, EXP NOV 2017; BAXTER 250ML BAG OF 0.9% NACL INJECTION NDC 0338-0049-02, LOT Y200469, EXP NOV 2017, THERAPY DATE (B)(6) 2016. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION ON INITIAL REPORT: DISREGARD LOT #, EXPIRATION DATE & DEVICE MANUFACTURE DATE

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT THE ENGAGEMENT BETWEEN THE IV TUBING AND THE TEXIUM BONDED LUER WHILE INFUSING CARBOPLATIN AS A SECONDARY INFUSION; DOSAGE AND RATE NOT SPECIFIED. THE PRIMARY LINE WAS INFUSING 0.9% NACL WITH (B)(4) AND MAGNESIUM 2G AT A RATE OF 500ML/HR. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM A TEXIUM BONDED SECONDARY SET AT THE TEXIUM CONNECTOR DURING AN INFUSION OF CARBOPLATIN , DOSAGE AND RATE NOT PROVIDED. THE LEAK OCCURRED DURING AN ACTIVE INFUSION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED; THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597756 ALARIS SECONDARY SET SET, SECONDARY, INTRAVASCULAR FPA CAREFUSION 10013364T 16066406

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)