BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEGEN SECONDARY SET

    MDR report key: 3060010 · Received March 19, 2013

    Report

    Report Number
    9616066-2013-00190
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS DISCARDED. THE CUSTOMER COMPLAINT OF ROLLER CLAMP DID NOT SHUT OFF THE IV DRIP AND THE AIR VENT CAP BROKE COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ROLLER CLAMP DID NOT SHUT OFF THE IV DRIP AND THE AIR VENT CAP BROKE. THE DOCTOR FELT THE ROLLER CLAMP WAS COMPLETELY CLOSED, BUT FLUID CONTINUED TO DRIP WHILE ON A PT. THIS EVENT OCCURRED AT A SURGERY CENTER. THERE WAS NO PT OR NURSE HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114530 MEDEGEN SECONDARY SET FPA CAREFUSION CORP MS3500-15 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK