BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PUMP SET WITH 0.2MICRON FILTER AND PA-ASV

    MDR report key: 1133051 · Received August 22, 2008

    Report

    Report Number
    9615050-2008-00223
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 29, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K023062
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF VANCOMYCIN. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING WAS NOTED TO BE SEPARATED AT THE FILTER CONNECTION. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR PUMP SET WITH 0.2MICRON FILTER AND PA-ASV 80-FRN FRN HOSPIRA DE COSTA RICA LTD. NA 580405H

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR