BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESP SYRINGE PUMP

    MDR report key: 778705 · Received March 23, 2006

    Report

    Report Number
    2027791-2006-00001
    Event Type
    Malfunction
    Date Received
    March 23, 2006
    Date of Event
    March 21, 2006
    Report Date
    March 23, 2006
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON MARCH 21, 2006, OUR TECHNICAL STAFF CALLED THE CUSTOMER'S BIOMEDICAL ENGINEERS, TO DISCUSS A SHIPMENT OF PUMPS THEY HAD PREVIOUSLY RETURNED, TO CLARIFY THE PROBLEM THEY HAD OBSERVED. DURING THIS DISCUSSION, IT BECAME CLEAR THAT THEY HAD BEEN TESTING THE PUMPS PRIOR TO PUTTING THEM INTO SERVICE IN THE HOSP AND FOUND THAT THE ALARMS WERE MALFUNCTIONING. THIS DISCUSSION CONFIRMED AN ON-GOING INTERNAL INVESTIGATION THAT HAD BEEN INITIATED. PLEASE NOTE THAT THERE HAVE BEEN NO NOTICES OF THIS MALFUNCTION REPORTED TO US AND THERE HAVE BEEN NO ACTUAL OR POTENTIAL INJURIES RELATED TO THESE PRODUCTS PREVIOUSLY REPORTED. BASED ON THIS INFO AND THE POTENTIAL OF PT RISK, EXCELSIOR IS INITIATING A PRODUCT RECALL AS OF 3/22/06 AND HAS DISCONTINUED FURTHER SALES OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESP SYRINGE PUMP INFUSION PUMP FRN EXCELSIOR MEDICAL CORP. ESP 140A & D ALL SERIAL NO

    Patients

    Seq Age Sex Outcome Treatment
    1 *