BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOSI-FUSER

    MDR report key: 2163497 · Received July 6, 2011

    Report

    Report Number
    MW5021293
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 6, 2011
    Manufacturer
    GRIFOLS, LEVENTON
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    COLON CANCER PT, WHO WAS RECEIVING FLUOROURACIL BY INFUSION PUMP WAS FOUND DISORIENTED ON THE FLOOR OF HER HOME. AT THE HOSPITAL SHE WAS ALSO FOUND TO HAVE EKG CHANGES. SHE WENT FOR CARDIAC CATHETERIZATION WHICH SHOWED NORMAL FINDINGS. CT AND MRI OF THE HEAD DID NOT SHOW ANY ACUTE CHANGES. PER THE PT'S HUSBAND THE AMBULATORY INFUSION PUMP WHICH SHOULD BE FINISHED LATER IN THE AFTERNOON WAS COMPLETED EARLY MORNING OF (B)(6) 2011. THIS WAS THE PT'S FIFTH CYCLE OF FOLFOX. CARDIOLOGIST, NEUROLOGIST, AND ONCOLOGIST BELIEVE THAT THERE MAY HAVE BEEN FLUOROURACIL INDUCED CARDIAC AND CEREBRAL TOXICITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOSI-FUSER PORTABLE ELASTOMERIC INFUSER MEB GRIFOLS, LEVENTON 101662L

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization