BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2081647 · Received April 27, 2011

    Report

    Report Number
    2016493-2011-00277
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP MODULE AND DEVICE EVENT LOGS WERE RECEIVED. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE PUMP MODULE ALARMED "PT SIDE OCCLUSION" DURING A DOPAMINE INFUSION. THE USER POWERED THE PUMP MODULE OFF AND ON, CHECKED THE IV SET BUT THE ALARM CONTINUED. THE PUMP MODULE WAS REPLACED, THE SAME IV TUBING WAS LOADED INTO THE REPLACEMENT PUMP MODULE AND THE INFUSION RESTARTED WITHOUT INCIDENT OR ALARMS. DURING THE TIME IT TOOK TO REPLACE THE PUMP MODULE THAT ALARMED, APPROXIMATELY 5 MINUTES, THE PT'S ARTERIAL BLOOD PRESSURE DECREASED TO 50 MMHG. ONCE THE DOPAMINE INFUSION WAS RESTARTED, THE PT'S BLOOD PRESSURE INCREASED BACK TO BASELINE AND STABILIZED. NO ADVERSE PT SEQUELAE REPORTED AND NO MEDICAL INTERVENTION REQUIRED. THE EVENT PUMP MODULE WAS EVALUATED BY BIOMED AND THE ALARM WAS CONFIRMED BY AN EVENT LOG REVIEW AND REPRODUCED. A NEW ADMINISTRATION SET WAS OBTAINED, AN INFUSION WAS PROGRAMMED AND STARTED AT THE EVENT RATE OF 40 ML/HR. AFTER 4 HOURS OF INFUSING INTO A BUCKET, THE PUMP MODULE ALARMED "PT SIDE OCCLUSION".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other ALARIS PUMP MODULE: (B)(4)| ALARIS PUMP MODULE: (B)(4)| ALARIS PUMP MODULE ADMINISTRATION SET: MODULE UNK| ALARIS PC UNIT: (B)(4)| LOT NUMBER UNK| ALARIS PUMP MODULE: (B)(4)