BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFUSE RAPID RATE INFUSER

    MDR report key: 884932 · Received September 28, 2006

    Report

    Report Number
    1419106-2006-00004
    Event Type
    Malfunction
    Date Received
    September 28, 2006
    Date of Event
    August 28, 2006
    Report Date
    August 28, 2006
    Manufacturer
    BAXA CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DEVICE MALFUNCTION. CUSTOMER REPORTS THAT A PT WAS UNDERGOING AN ADENOSINE NST (NON-STRESS TEST) USING A MICROFUSE RAPID RATE INFUSER. AFTER APPROX 2 MINUTES, 45 SECONDS OF INFUSION THE CUSTOMER REPORTS THAT THE PUMP ADMINISTERED A BOLUS OF ADENOSINE NST. CUSTOMER REPORTS THE PT BECAME DIZZY AND EXPERIENCED A DECREASED HEART RATE. THE ADMINISTRATION LINE WAS IMMEDIATELY CLAMPED AND THE INFUSER ALARMED. ADMINISTRATION WAS DISCONTINUED AND THE PT RECOVERED IMMEDIATELY. CUSTOMER REPORTS NO PT INJURY/ILLNESS OR MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER HAS BEEN CONTACTED FOR MORE INFO REGARDING THE INCIDENT. THE MICROFUSE HAS BEEN RECEIVED BY BAXA CORPORATION AND IS CURRENTLY BEING EVALUATED. A FOLLOW-UP MDR WILL BE SUBMITTED AT THE COMPLETION OF EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFUSE RAPID RATE INFUSER PUMP, SYRINGE FRN BAXA CORP. 6001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other