BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1050340 · Received May 23, 2008

    Report

    Report Number
    9616066-2008-00020
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE IV TUBING SEPARATED RESULTING IN AN UNDER INFUSION OF VASOPRESSIN AND LEVOPHED LEADING TO HYPOTENSION (BP 50/20) IN A CRITICALLY ILL PT. THE NURSE WAS TRANSPORTING THE PT FROM CT SCAN BACK TO THE NEURO ICU WHERE HE OBSERVED BLOOD AND FLUID LEAKING FROM THE FEMORAL VENOUS IV SITE AND FOUND THAT THE IV TUBING HAD SEPARATED RESULTING IN THE VASOPRESSIVE MEDICATIONS NOT INFUSING INTO THE PT. ONCE BACK IN THE NEURO ICU, THE IV TUBING WAS CHANGED AND BOTH MEDICATION INFUSIONS WERE RESTARTED. AFTER THE VASOPRESSIN AND LEVOPHED WERE RESTARTED, THE PT'S BLOOD PRESSURE RETURNED TO BASELINE. THE PT WAS MONITORED AND NO ADD'L MEDICAL INTERVENTION REQUIRED OR ILL EFFECTS EXPERIENCED BY THE PT. IV ADMINISTRATION SET REC'D. INVESTIGATION IS ON-GOING. F/U WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA, SET ADMINISTRATION FPA CARDINAL HEALTH ALARIS PRODUCTS 2426-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention