BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRN CRONO SYRINGE

    MDR report key: 1293729 · Received January 15, 2009

    Report

    Report Number
    MW5009644
    Event Type
    Injury
    Date Received
    January 15, 2009
    Date of Event
    January 14, 2009
    Report Date
    January 15, 2009
    Manufacturer
    PONTAFORTO
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAS PULMONARY HYPERTENSION AND RECEIVES IV REMODULIN THROUGH A 6.6 FRINCH BROVIAC CENTRAL VENOUS CATHETER. HER HOME INFUSION PUMP IS THE CRONO-5 PUMP WITH THE CRONO SYRINGE. PT FELT VERY SHORT OF BREATH AND CHECKED TO ENSURE THAT THE PUMP WAS INFUSING HER MEDICATION. THE PUMP WAS INFUSING; HOWEVER, THE PT NOTED A LARGE AIR BUBBLE WAS IN THE SYRINGE RESERVOIR THAT WAS NOT THERE PREVIOUSLY. IN ADDITION, THERE WAS BLOOD BACKING UP IN CVL LINE. SHE ACTIVATED THE EMERGENCY PAGER AND SHE WAS ADVISED TO GO TO THE LOCAL ER. UPON ASSESSMENT AT THE ER, THE STAFF REPORTED THAT SHE WAS PALE, SHORT OF BREATH AND THE LINE HAD CLOTTED OFF. SHE WAS ADMINISTERED OXYGEN AND THE IV REMODULIN WAS RESTARTED THOUGH A PIV. THE BROVIAC LINE WAS TREATED WITH ONE ROUND OF TPA WHICH WAS SUCCESSFUL IN CLEARING THE LINE. SHE WAS ADMITTED OVER NIGHT FOR OBSERVATION FOR EMBOLUS. SHE WAS STABLE THERE AFTER AND WAS DISCHARGED IN EARLY 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRN CRONO SYRINGE NONE FMF PONTAFORTO

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| L