BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSREAM PUMP 20 ML

    MDR report key: 2230680 · Received August 17, 2011

    Report

    Report Number
    1226348-2011-00309
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MFG RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVAL WILL REVEAL THAT THE DEVICE CONFORMED TO SPECS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A F/U REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A F/U REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION THE NATURE OF THIS COMPLAINT IS A KNOWN COMPLICATION OF INTERFERENCE WITH MRI FOR WHICH A TECHNICIAN KEY IS DEPLOYED TO RESET THE PUMP THAT MAY HAVE BEEN AFFECTED BY MR INTERFERENCE. IT SHOULD ALSO BE NOTED THAT THE INSTRUCTIONS FOR USE HAVE BEEN UPDATED TO REFLECT THE PROCESS IN WHICH TO RESOLVE THIS KNOWN ISSUE. REGARDING THE COMMENT PERTAINING TO OVERFILL, THE CONTROL UNIT SOFTWARE COULD NOT DISPLAY A VALUE SUPERIOR TO 20.0 ML, EVEN IF AN OVERFLOW OCCURRED. AS NO TRANSACTION LOGS WERE PROVIDED BY THE CUSTOMER, IT WAS NOT POSSIBLE TO CONFIRM THIS DEFECT. IF WE RECEIVE THOSE TRANSACTION LOGS IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE PRODUCT CONFORMED TO THE SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLIANT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PUMP DISPLAYED A HARDWARE FAILURE 11 AFTER A MRI SCAN. THE PUMP WAS RESTARTED WITH A TECHNICIAN KEY. TWENTY HOURS LATER THE SURGEON REPORTED THAT AFTER AN ENTIRE DAY THE AMOUNT OF MEDICATION IN THE PUMP DID NOT DECREASE. WHEN THE SURGEON ASPIRATED THE PUMP HE REALIZED THE PUMP HAD BEEN OVER FILLED. WHEN 5 ML WERE ASPIRATED THE PUMP REGISTERED CORRECTLY. ALTHOUGH THIS PRODUCT HAS BEEN APPROVED IN THE UNITED STATES THERE HAVE BEEN NO SALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDSREAM PUMP 20 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN AND SHURTLEFF - RAYNHAM NA NKBFYJ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention