BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMIN SET

    MDR report key: 3941485 · Received April 16, 2014

    Report

    Report Number
    9616066-2014-00405
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    January 22, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION - UNDETERMINED OR UNK CAUSE. THE CUSTOMER'S REPORT OF TUBING BROKEN AT THE TOP WAS CONFIRMED. VISUAL INSPECTION REVEALED THAT THE SILICON SEGMENT HAD A TER NEAR THE UPPER BLUE FITMENT THAT MEASURES APPROXIMATELY 0.0283 INCHES. THREE CRUSH MARKS WERE NOTED ON THE UPPER FITMENT. PRESSURE TESTING CONFIRMED A LEAK AT THE TEAR. THE CAUSE OF THE LEAK WAS A TEAR IN THE SILICON SEGMENT. ROOT CAUSE WAS NOT IDENTIFIED HOWEVER, DUE TO THE CRUSH MARKS ON THE UPPER FITMENT, IT IS POSSIBLE THE SET WAS MISLOADED INTO THE PUMP CAUSING A TEAR ON THE SILICONE SEGMENT WHEN THE DOOR WAS CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TUBING IS "BROKEN AT THE TOP". THER WAS NO PT INVOLVEMENT. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232259 ALARIS PUMP MODULE ADMIN SET FPA CAREFUSION CORP 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA