BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY TUBING SET, 3 Y-SITES, PINCH CLAMP

    MDR report key: 1061824 · Received June 13, 2008

    Report

    Report Number
    9615050-2008-00166
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    March 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K03002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER SALINE. UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT VIA AN UNSPECIFIED INFUSION PUMP. THE CUSTOMER CONTACT REPORTED THE PINCH CLAMP ON THE PRIMARY TUBING SET WAS CLOSED TO STOP THE FLOW. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT NOTED THAT SOLUTION CONTINUED TO DRIP FROM THE PRIMARY TUBING SET. THE CUSTOMER CONTACT STATED THAT THE PRIMARY AND SECONDARY SOLUTIONS WERE ALLOWED TO CONTINUE TO BE DELIVERED TOGETHER UNTIL THE SECONDARY INFUSION WAS COMPLETE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TUBING SET, 3 Y-SITES, PINCH CLAMP 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA 611795H

    Patients

    Seq Age Sex Outcome Treatment
    1