BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ

    MDR report key: 1061974 · Received May 30, 2008

    Report

    Report Number
    1061974
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 30, 2008
    Manufacturer
    UNIVERSAL HOSPITAL SERVICES (UHS)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SINGLE SYMBIQ PUMP FAILED DURING INFUSION OF SODIUM CHLORIDE. DISTAL OCCLUSION ALARM PERSISTED DESPITE MULTIPLE STAFF INTERVENTIONS. THE IV FLOWED FINE WITHOUT THE PUMP VIA THE IV LINE. THE SYMBIQ PUMP WAS PULLED FROM SERVICE AND RETURNED TO THE RENTAL AGENCY FOR THEIR EVALUATION. THEIR EVALUATION REVEALED THAT THE ALARM LOG DISPLAYED THAT THE PROXIMAL OCCLUSION HAD ALARMED SIX TIMES AND THE CHECK CASSETTE ALARM ONCE FROM 18:28 TO 18:30. THE PUMP DID PASS INSPECTION WITH NO REPAIRS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ PUMP, IV FRN UNIVERSAL HOSPITAL SERVICES (UHS) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR