BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 5446998 · Received February 19, 2016

    Report

    Report Number
    9616066-2016-00209
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    January 20, 2016
    Report Date
    January 22, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 500ML BAXTER INFUSION BAG OF 20MEQ KCL IN 5% DEXTROSE AND 0.45% NACL INJ. USP (LOT #Y003376, EXP. 05/17, NDC 0338-0671-04); 100ML BAXTER INFUSION BAG OF 5% DEXTROSE INJ. USP (LOT #P342502, EXP. 05/17), NDC 0338-0017-38); NON-BD SECONDARY SET; THERAPY DATE: (B)(6) 2016. THE CUSTOMER¿S REPORT OF A LEAK AT ONE OF THE Y-SITES WAS CONFIRMED. VISUAL INSPECTION INCLUDING USE OF MAGNIFICATION DID NOT REVEAL ANY DAMAGE OR ANOMALIES ON THE SET AND ITS COMPONENTS. FUNCTIONAL TESTING CONFIRMED LEAKING AT THE ENGAGEMENT OF THE TUBING TO THE VERSASAFE OUTLET PORT. THE ROOT CAUSE OF THE LEAK WAS IDENTIFIED AS A MANUFACTURING ISSUE DUE TO INSUFFICIENT SOLVENT BEING APPLIED AT THE ENGAGEMENT OF THE TUBING TO THE VERSASAFE OUTLET PORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED FROM CUSTOMER MEDWATCH.

    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.

    Description of Event or Problem · 1

    RECEIVED A MEDWATCH REPORT: EVENT DESC: IV TUBING WAS LEAKING FROM ONE OF THE JOINTS IN THE TUBING. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT ONE OF THE Y-SITE VALVES IN THE TUBING. THERE IS NO FURTHER INFORMATION REGARDING THIS EVENT, AND NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103745 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2123-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR