BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEXITRON EQUIPO GRAVITACIONALP/ ADM.DE SOLU?OES MACROGOTAS

    MDR report key: 1943115 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06495
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF NO FLOW WAS CONFIRMED DUE TO A DEFECT IN DRIP CHAMBER. THE DRIP CHAMBER IS PRODUCED BY AN OUTSIDE SUPPLIER. THE SUPPLIER WILL BE NOTIFIED OF THIS REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A NO FLOW. THE REPORTED CONDITION OCCURRED BEFORE USE. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXITRON EQUIPO GRAVITACIONALP/ ADM.DE SOLU?OES MACROGOTAS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SAO PAULO PE26S1

    Patients

    Seq Age Sex Outcome Treatment
    1