BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM MR INFUSION SYSTEM ADMINISTRATION SET

    MDR report key: 2536855 · Received April 10, 2012

    Report

    Report Number
    2520313-2012-00016
    Event Type
    Malfunction
    Date Received
    April 10, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 9, 2012
    Manufacturer
    MEDRAD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDRAD QUALITY ASSURANCE PRODUCT ANALYSIS RECEIVED AND TESTED THE CONTINUUM PUMP TO DETERMINE THE ROOT CAUSE OF THE UNDER INFUSION ISSUE. THE SITE COULD NOT PROVIDE ANY LOT NUMBERS OF THE MEDRAD CONTINUUM MR INFUSION SYSTEM STANDARD ADMINISTRATION KIT (MIK 200A) THAT WERE INVOLVED WITH ANY OF THESE INCIDENTS. 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

    WE RECEIVED THE FOLLOWING INFORMATION: WHILE USING THE MEDRAD CONTINUUM MR INFUSION PUMP (SERIAL NUMBER (B)(4)) AND THE MEDRAD CONTINUUM MR INFUSION SYSTEM STANDARD ADMINISTRATION KIT (MIK 200A), THE SITE REPORTED THAT THE PUMP HAD DELIVERED LESS THAN PRESCRIBED WHILE INFUSING PROPOPHOL DURING MORE THAN ONE PEDIATRIC CASE. THE SITE WAS UNABLE TO DISCLOSE SPECIFIC INFORMATION TO THE EXACT DATES OF THESE ALLEGATIONS, BUT INDICATED THAT UNDER INFUSION OF MORE THAN 10% HAD OCCURRED. AS A RESULT, ADDITIONAL DOSING WAS INDICATED WHEN THE PTS BEGAN TO AWAKEN SOONER THAN ANTICIPATED. THE SITE WOULD MANUALLY BOLUS THE CONTINUUM PUMP WITH PROPOPHOL TO OVERCOME THIS SITUATION. THERE WAS NO INJURY REPORTED IN ANY OF THESE INCIDENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDRAD CONTINUUM MR INFUSION PUMP