BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2935114 · Received January 23, 2013

    Report

    Report Number
    2016493-2013-00072
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 3, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND LOG REVIEW IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A "RAPID INFUSION" EVENT. A REMICADE INFUSION WAS STARTED (250 MLS TO GO OVER 2 HOURS). THE FIRST 80 MINUTES OF THE INFUSION WENT WELL, THEN THE PT CALLED THE NURSE TO REPORT THAT THE REMAINDER OF THE MEDICATION INFUSED OVER 2-3 MINUTES. THE PT DEVELOPED A SEVERE HEADACHE AND HYPERTENSION. THE PT WAS TREATED WITH CLONIDINE 0.1MG SUBLINGUAL X1 DOES FOR B/P 190/102, HR 82. B/P CHECKS WERE ORDERED FOR EVERY 5-10 MINUTES. THE PT WAS ALSO GIVEN SUMATRIPTAN 100MG FOR HEADACHE X2. PT WAS DISCHARGED HOME. CUSTOMER STATED THAT NO ADDITIONAL PT OR EVENT DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33705 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention ALARIS PUMP MODULE ADMIN SET, MODEL/LOT# UNK| ALARIS PC UNIT, SN (B)(4)