BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIOR SYRINGE PUMP

    MDR report key: 320627 · Received March 12, 2001

    Report

    Report Number
    MW1021317
    Event Type
    Injury
    Date Received
    March 12, 2001
    Date of Event
    March 12, 2001
    Report Date
    March 12, 2001
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEERING DEPT HAS BEEN RECEIVING UP TO 40 PUMPS A WEEK WITH CASE DAMAGE TO THE PUMP AND SYRINGE HOLDERS. INSPECTIONS FOUND THE PLASTIC INSIDE OF THE PUMP NEAR THE BATTERY BASE CRACKED AND DISLODGED CAUSING THE PUMP TO STOP DURING ADMINISTRATION OF MEDICATIONS. THERE IS ALSO DAMAGE TO THE AREAS NEAR THE BATTERY CAP CAUSING THE SAME PUMP STOPPAGE PROBLEMS. CURRENT SOLUTION IS THE REPLACEMENT OF THE FRONT AND REAR CASES BUT PROBLEM IS RECURRING EVEN WITH NEW CASES. BIOMEDICAL CONCLUDES THAT PLASTIC CASES ARE WEAK AND WILL BREAK EASILY IF DROPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11000 EXCELSIOR SYRINGE PUMP SYRINGE PUMP FRN EXCELSIOR MEDICAL CORP. ESP 60CC VER. *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention