BEUDAMED
    FDA Adverse Event Summary report: N

    MEDRAD CONTINUUM MR COMPATIBLE INFUSION DEVICE

    MDR report key: 4931785 · Received July 22, 2015

    Report

    Report Number
    2520313-2015-00039
    Date Received
    July 22, 2015
    Date of Event
    May 28, 2015
    Report Date
    June 29, 2015
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    FRN
    PMA / PMN Number
    K021988
    Removal / Correction Number
    605-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE PLACED THE CONTINUUM MR INFUSION PUMP UNDER QUARANTINE IMMEDIATELY FOLLOWING THE REPORTED INCIDENT. MULTIPLE DOCUMENTED ATTEMPTS WERE MADE TO HAVE THE CONTINUUM PUMP RETURNED TO BAYER MEDICAL CARE, INC. FOR EVALUATION, AS WELL AS, TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT WITH NO SUCCESS. BASED ON THE LIMITED INFORMATION, WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE ALLEGED MEDICATION OVER INFUSION. IN THE EVENT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IN (B)(4) 2014, BAYER HEALTHCARE ANNOUNCED A DECISION TO PERMANENTLY REMOVE THE CONTINUUM MR INFUSION SYSTEM FROM THE FIELD WITHOUT REPLACEMENT (FDA # (B)(4)). THE DECISION TO REMOVE THE PRODUCT FROM THE FIELD WAS OFFICIALLY COMMUNICATED TO THIS CUSTOMER IN WRITING ON (B)(6) 2014. AFTER FAILING TO RECEIVE A RESPONSE FROM THE CUSTOMER, FOLLOW UP LETTERS WERE SENT ON (B)(6) 2015 AND THEN AGAIN ON (B)(6) 2015.

    Description of Event or Problem · 1

    ON (B)(4) 2015, WE RECEIVED A COPY OF MEDWATCH, UF/IMPORTER # (B)(4). THE CUSTOMER REPORTED THAT AN ALLEGED OVER INFUSION OF TISSUE PLASMINOGEN ACTIVATOR (TPA) HAD OCCURRED WHILE A PATIENT WAS CONNECTED TO A CONTINUUM MR INFUSION SYSTEM. IN THIS REPORT IT WAS STATED THAT "PUMP MAY HAVE BEEN PROGRAMMED INCORRECTLY. NO PATIENT HARM OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474539 MEDRAD CONTINUUM MR COMPATIBLE INFUSION DEVICE INFUSION PUMP FRN BAYER MEDICAL CARE, INC. 3015725

    Patients

    Seq Age Sex Outcome Treatment
    1 Other