BEUDAMED
    FDA Adverse Event Other Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 1310506 · Received February 10, 2009

    Report

    Report Number
    3005053560-2009-00001
    Event Type
    Other
    Date Received
    February 10, 2009
    Date of Event
    November 7, 2008
    Report Date
    February 9, 2009
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT FROM THE HEALTHCARE PROFESSIONAL INDICATED THAT THE DEVICE (INFUSION PUMP AND INFUSION SET) WAS EVALUATED BY THE HOSPITAL STAFF. FOLLOWING THE EVENT, THE EQUIPMENT WAS REQUESTED TO BE RETURNED TO IRADIMED CORPORATION FOR EXAMINATION. THIS EQUIPMENT WAS NOT EVALUATED BY THE MANUFACTURER, AS THE CUSTOMER INDICATED THAT THE PRODUCT DID NOT MALFUNCTION, AND DID NOT REQUIRE TO BE EVALUATED BY THE MANUFACTURER. ALL INFORMATION WAS OBTAINED FROM CUSTOMER INTERVIEWS, AND THE CUSTOMER'S INSPECTION OF THE INFUSION PUMP. THE INFUSION PUMP IS PRESENTLY IN USE AT THE HOSPITAL. INVESTIGATION CONCLUSION: FROM OUR INVESTIGATION, THE PROBABLE CAUSE OF THIS EVENT WAS THE USE OF THE PUMP WITHOUT SUFFICIENT TRAINING FOR THE STAFF USING THE PUMP. NO MALFUNCTION OR DEVICE FAILURE WAS OBSERVED, AND THE HOSPITAL STAFF WAS AWARE THAT ADDITIONAL TRAINING IS REQUIRED. ADDITIONAL TRAINING HAS BEEN PERFORMED SINCE THE EVENT. THIS FAILURE IS CONSIDERED AN UNUSUAL AND ISOLATED INCIDENT. NO OTHER ACTION IS CONSIDERED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    A MRIDIUM 3850 PUMP WAS TAKEN TO THE ICU TO ACCOMPANY A PT TO THE MRI. APPARENTLY, THE ICU NURSE PREPARING THE PUMP FOR USE WITH THE PT HAD NEVER SEEN OR BEEN TRAINED IN THE USE OF THE PUMP. THE PUMP WAS SET UP WITH THE 1055 BYPASS IV SET, AND DURING THE INITIAL SETUP, SHE APPARENTLY LEFT OPEN THE ROLLER CLAMP OF THE MAIN IV SET (ALARIS IV SET). THE PT RECEIVED APPROX 200ML OF DOPAMINE FROM THE IV BAG. THE PATIENT BECAME "FLUSHED" BUT THE PT WAS FINE FOLLOWING THE EVENT. THE PATIENT'S MRI WAS PERFORMED FOLLOWING THE EVENT. NO INJURY RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention