BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6041711 · Received October 19, 2016

    Report

    Report Number
    9616066-2016-01478
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 7, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 EXACTAMIX BAG DEXTROSE, REF (B)(4), LOT 1153568, EXP (B)(6) 2019; B.BRAUN 150ML BAG OF 0.9% NACL INJECTION, NDC (B)(4), 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

    THE CUSTOMER¿S REPORT OF TUBING LEAKED WAS CONFIRMED. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO ANOMALIES WERE OBSERVED ON THE SET. FUNCTIONAL TESTING RESULTED IN THE SET FLOWING FREELY AND RAN WITH NO ISSUES. PRESSURE TESTING CONFIRMED AIR BUBBLES LEAKING AT THE TOP ENGAGEMENT OF THE TUBING AND THE DISTAL Y-SITE INLET PORT AT 5 PSI. DIMENSIONAL ANALYSIS WAS PERFORMED AND FOUND THE SET TO BE WITHIN SPECIFICATION. THE PROBABLE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF TUBING LEAKED WAS IDENTIFIED AS A MANUFACTURING ISSUE DUE TO INSUFFICIENT SOLVENT BEING APPLIED AT THE JUNCTION OF THE VINYL TUBING AND Y-SITE INLET PORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBING LEAKED AT AN UNSPECIFIED LOCATION. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBING LEAKED TPN AT AN UNSPECIFIED LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691776 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2126-0007 14036415

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA NON-CFN TUBING,