BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6843067 · Received September 5, 2017

    Report

    Report Number
    9616066-2017-01254
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 22, 2017
    Report Date
    August 25, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF FLUID LEAKAGE AT THE CONNECTION SITE OF A NON-BD SECONDARY SET WITH TEXIUM ATTACHED AND THE SMARTSITE OF A PRIMARY SET WAS CONFIRMED. MICROSCOPIC INSPECTION OF THE UPSTREAM SMARTSITE VALVE ON THE PRIMARY SET REVEALED UPTURNED EDGES ON THE VALVE THREADS AND A VERTICAL HAIRLINE CRACK, INDICATIVE OF STRESS. THERE WERE NO ADDITIONAL SIGNS OF DAMAGE OR ABNORMALITIES WITH THE TUBING SET OR TEXIUM VALVE. FUNCTIONAL TESTING RESULTED IN NO LEAKING. PRESSURE TESTING CONFIRMED LEAKING AT THE TEXIUM-TO-SMARTSITE CONNECTION. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 500ML BAXTER INFUSION BAG, LOT Y222406, EXP (B)(6), THERAPY DATE (B)(6) 2017. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A FLUID LEAKED AT THE Y-SITE CONNECTION ON THE PRIMARY TUBING DURING A SECONDARY INFUSION OF IRINOTECAN HYDROCHLORIDE 240MG IN 500 ML 5% DEXTROSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF IRINOTECAN AT THE Y-SITE CONNECTION TO THE PRIMARY TUBING DURING AN INFUSION. THE TEXIUM WITH THE NON-BONDED SECONDARY SET WAS ATTACHED TO THE Y-SITE OF THE PRIMARY LINE WHEN IT LEAKED. THE SECONDARY SET WAS CHANGED AND THE LEAK CONTINUED UNTIL THE PRIMARY TUBING WAS CHANGED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623399 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1