BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2091459 · Received May 4, 2011

    Report

    Report Number
    2016493-2011-00304
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 7, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 05/04/2011. (B)(4). THE DEVICES HAVE BEEN RECEIVED BUT THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN DONE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNDER INFUSION OF AMIODARONE. THE DETAILS ARE AS FOLLOWS: THE PATIENT HAD A CARDIOLOGY CONSULT ON (B)(6) 2011 AND THEN HAD A CARDIAC CATHETERIZATION. HE THEN HAD A CABG (CORONARY ARTERY BYPASS GRAFT) ON (B)(4) 2011. HE WAS TRANSFERRED FROM THE SICU TO THE GENERAL WARD ON (B)(6) 2011 ABOUT 14:30. AT 16:25, THE PATIENT DEVELOPED A RAPID RATE AND ATRIAL FLUTTER 2:1. HE WAS BOLUSED WITH AMIODARONE 150MG. ANOTHER BOLUS WAS GIVEN AT 17:15. HE WAS GIVEN LOPRESSOR 12.5MG AT 17:36 AND THE RAPID RESPONSE TEAM WAS CALLED AT 18:06 DUE TO THE ATRIAL FLUTTER. THE PATIENT'S HEART RATE WAS 130-133, B/P STABLE 120/60S AND ASYMPTOMATIC. POTASSIUM REPLACEMENT GIVEN AT 18:11 AND LOPRESSOR 5MG AT 19:00. AMIODARONE DRIP WAS FOUND TO BE UNDER INFUSION (MISPROGRAMMED) AT 22:00. THE PATIENT WAS TRANSFERRED BACK TO THE SICU AT 23:38. ESMOLOL DRIP AND AMIODARONE GIVEN. HEMOGLOBIN WAS 7.7, SO THE PATIENT RECEIVED 2 UNITS OF BLOOD. PATIENT WAS SUCCESSFULLY CARDIOVERTED ON (B)(6) 2011 AT 22:00. HE WAS TRANSFERRED BACK TO THE GENERAL WARD AND THEN DISCHARGED HOME ON (B)(6) 2011. IT IS NOT KNOWN WHETHER THERE IS A RELATIONSHIP BETWEEN UNDER INFUSION OF AMIODARONE AND THE PATIENT REVERTING TO ATRIAL FLUTTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening ALARIS PUMP MODULE: S/N (B)(4)| ALARIS PC UNIT: S/N (B)(4)