BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2181031 · Received July 25, 2011

    Report

    Report Number
    2181031
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 22, 2010
    Report Date
    July 7, 2010
    Manufacturer
    HOSPIRA
    Product Code
    FPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN AIR-IN-LINE FILTER WAS IN USE ON A PERIPHERAL INFUSION LINE. WHEN STAFF ATTEMPTED TO SWITCH THE INFUSION TO A CENTRAL LINE ACCESS, THE FILTER EXTENSION SET WOULD NOT ALLOW THE INFUSION TO CONTINUE. LEVOPHED (CENTRAL CONCENTRATION) WAS CHANGED OVER ONCE THIS PATIENT HAD A CENTRAL LINE PLACED. THE PERIPHERAL CONCENTRATION WAS STOPPED. PATIENT'S BLOOD PRESSURE WAS NOTED TO DROP RAPIDLY VIA ARTERIAL LINE MONITORING. THE CUFF PRESSURE CONFIRMED THIS DROP. THE NURSE NOTICED THE CENTRALLY CONCENTRATED LEVOPHED DRIP DID NOT APPEAR TO BE ADVANCING THROUGH THE TUBING AROUND THE FILTER. THE FILTER WAS REMOVED AND LINE REATTACHED. AFTER 2 MINUTES, THE PATIENT BLOOD PRESSURE STARTING TO RESPOND TO THE CENTRALLY CONCENTRATED LEVOPHED INFUSION.======================MANUFACTURER RESPONSE FOR AIR-ELIMINATING FILTER, (BRAND NOT PROVIDED) (PER SITE REPORTER)======================REGIONAL FIELD REPRESENTATIVE PROVIDED CONTACT PHONE NUMBER FOR END-USERS TO REPORT PROBLEMS WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * AIR-ELIMINATING FILTER FPB HOSPIRA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR CARDIAC DRUGS