BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM INFUSION SYSTEM ADMINISTRATION SET

    MDR report key: 2517934 · Received April 2, 2012

    Report

    Report Number
    2520313-2012-00010
    Event Type
    Malfunction
    Date Received
    April 2, 2012
    Date of Event
    October 6, 2011
    Report Date
    October 6, 2011
    Manufacturer
    MEDRAD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDRAD QUALITY ASSURANCE PRODUCT ANALYSIS RECEIVED AND TESTED THE CONTINUUM PUMP AND THE MEDRAD CONTINUUM MR INFUSION SYSTEM STANDARD ADMINISTRATION KIT (MIK 200A), LOT NUMBER 112729, TO DETERMINE THE ROOT CAUSE OF THE UNDER INFUSION ISSUE. PRELIMINARY INVESTIGATION AND ANALYSIS APPEARS TO INDICATE THAT CERTAIN LOT NUMBERS OF THE MIK 200A EXHIBIT VARIATION IN SPECIFICATIONS THAT MAY IMPACT THE FUNCTIONALITY OF THE PUMP AND THEREFORE MAY BE CONTRIBUTING TO THE UNDER INFUSION OF MEDICATION REPORTED BY THIS SITE. THIS INVESTIGATION AND ANALYSIS IS CONTINUING.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING INFO: WHILE USING THE MEDRAD CONTINUUM MR INFUSION PUMP (SERIAL NUMBER (B)(4)) AND THE MEDRAD CONTINUUM MR INFUSION SYSTEM STANDARD ADMINISTRATION KIT (MIK 200A), LOT NUMBER 112729, THE SITE REPORTED THAT THE PUMP WAS DELIVERING LESS THAN PRESCRIBED DURING AN ANESTHESIA PROCEDURE AND SUBSEQUENTLY THE PT WOKE UP DURING THE SCAN. A PT INCIDENT REPORT WAS FILED BY THE SITE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM INFUSION SYSTEM ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA MEDRAD 3008301 112729

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDRAD CONTINUUM MR INFUSION PUMP