BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PUMP 40 ML

    MDR report key: 6992493 · Received October 31, 2017

    Report

    Report Number
    8031062-2017-00007
    Event Type
    Injury
    Date Received
    October 31, 2017
    Report Date
    August 30, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    LKK
    UDI-DI
    10886704043164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2017-00007. CONCLUSION: THE VALUES ARE CONSISTENT WITH THE EXPECTED STATUS AND SENSOR MEASUREMENTS. THE CORRESPONDING TEMPERATURE MEASUREMENT IS 34.63°C AND THE FLS FREQUENCY MEASUREMENT IS 275194 HZ WHICH CORRESPONDS TO 24.7 ML. IT WAS NOTED A BIR INTEGRITY ERROR PRESENT. THOSE DATA WERE ANALYZED DURING A FIELD VISIT AND IT WAS CONCLUDED THAT THE PUMP ERRORS FLAGS COULD BE CLEARED AND THAT THE PHYSICIAN COULD RESUME THE MEDICATION. THE PUMP ERRORS WERE SUCCESSFULLY CLEARED USING A TECHNICIAN HARDWARE KEY PLUGGED IN THE PHYSICIAN¿S CU, A SELF-TEST HAS BEEN FORCED. THE PUMPS STATUS, ERROR AND SENSORS WHERE CHECKED AFTER THE ¿CLEAR ERROR¿ AND SEEMS ALL CONSISTENT. THE PHYSICIAN RESTARTED THE PROGRAM. IT WAS RECOMMENDED TO CONTROL THE PUMP DATA (STATUS, ERRORS AND SENSORS) AT THE NEXT REFILL TO ENSURE THE BIR INTEGRITY ERROR THAT WAS OBSERVED WILL NOT BE PRESENT ANYMORE. THE TRANSACTION LOGS FROM (B)(6)2017 TO (B)(6)2017 RELATED TO PUMP SERIAL NUMBER (B)(4) WERE RECEIVED ON (B)(6)2017 AND (B)(6)2017 . ANALYSIS OF THE TRANSACTION LOGS REVEALED THAT THE PUMP HAD TRIGGERED A HARDWARE FAILURE 11 ON (B)(6)2017. THE COMPLAINT WAS CONFIRMED BASED ON THE PUMP INTERROGATION PERFORMED DURING FIELD VISIT ON AUGUST 31, 2017, BY MEANS OF A HARDWARE TECHNICIAN KEY. IT WAS OBSERVED A "HARDWARE FAILURE [11]". IT WAS DETERMINED THAT THE PUMP FAILURE WAS NOT RELATED TO THE PUMP HARDWARE INTEGRITY, BUT MOST PROBABLY TO A POSSIBLE INTERFERENCE WITH THE MRI EXAMINATION ONTO THE PUMP. THE PIB WAS CALLED AND RECOMMENDED TO CLEAR THE ERROR FLAGS BASED ON THE DATA COLLECTED. CORRECTIVE ACTION (CAPA-(B)(4) ) WAS IMPLEMENTED TO AVOID THIS DEFECT, EFFECTIVENESS HAS BEEN DEMONSTRATED FOR PUMPS MANUFACTURED AFTER CAPA IMPLEMENTATION (SEPTEMBER 2010). THE PUMP INVOLVED IN THIS COMPLAINT WAS MANUFACTURED PRIOR THE IMPLEMENTATION OF THE CAPA.

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2017-00007. (B)(4). THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS HOWEVER A DEVICE HISTORY RECORD REVIEW IS CURRENTLY BEING CONDUCTED AND THE RESULTS ARE NOT YET AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2017-00007. CONCLUSION: BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST MRI IMAGING, THE PUMP HAD AN ALARM SIGNAL. PATIENT HAD TO UNDERGO MRT EXAMINATION ON (B)(6) 2017. HE WENT TO HOSPITAL ON (B)(6) AND REPORTED AN ALARM SOUND OF THE PUMP. ERROR 11 WAS READ OUT. SALES REP CHECKED THE PUMP ACCORDING TO PROCEDURE WITH TECHNICAL SUPPORT FROM LELOCLE. THE ERROR WAS RESOLVED AND PUMP WAS BE STARTED PROPERLY. THERE IS NO REPORT OF HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770515 MEDSTREAM PUMP 40 ML INFUSIONP UMP,IM PLANTABLEP,R OGTAMNABLE LKK MEDOS INTERNATIONAL SARL NA UNK 10886704043164

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention