BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 5251413 · Received November 25, 2015

    Report

    Report Number
    9616066-2015-01684
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Report Date
    November 11, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BAXTER, 500ML IV BAG OF 0.9% SODIUM CHLORIDE, LOT: C990002, EXP: DECEMBER 2016. THE CUSTOMER¿S REPORT OF IV TUBING SEPARATION ¿TEAR¿ WAS CONFIRMED. VISUAL INSPECTION OBSERVED THAT THE SILICONE SEGMENT HAD A TEAR NEAR THE UPPER FITMENT. THE TEAR MEASURED 0.0581 INCHES LONG. VISUAL EXAMINATION UNDER A MICROSCOPE NOTED NO CRUSH MARKS TO THE UPPER BLUE FITMENT. NO OTHER ANOMALIES WERE NOTED DURING VISUAL INSPECTION. FUNCTIONAL TESTING WAS PERFORMED; A LEAK WAS OBSERVED COMING OUT FROM THE SILICONE TUBING NEAR THE UPPER FITMENT. THE SET WAS PRESSURE TESTED WHILE SUBMERGED UNDERWATER AT 30 PSI OF AIR; LEAKING WAS OBSERVED AT THE SILICONE TUBING AT LESS THAN 3PSI OF AIR. THE ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SEPARATION OF AN IV TUBING DURING AN INFUSION OF AN UNSPECIFIED MEDICATION OR FLUID. THERE IS NO REPORT OF PATIENT HARM; ADDITIONAL DETAILS ARE NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781127 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0500

    Patients

    Seq Age Sex Outcome Treatment
    1