BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PUMP 40 ML

    MDR report key: 7496660 · Received May 8, 2018

    Report

    Report Number
    8031062-2018-00502
    Event Type
    Injury
    Date Received
    May 8, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 12, 2018
    Manufacturer
    MEDOS SARL
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00502. CONCLUSION: THE TRANSACTION LOG OF PUMP INTERROGATION PERFORMED ON (B)(6) 2018 SHOWED THAT THE PUMP HAD TRIGGED A HARDWARE FAILURE [8]. THE DEVICE HISTORY RECORD OF PRODUCT CODE 91-4201, LOT CLCBB3; SERIAL NUMBER (B)(4) WAS REVIEWED AND CONFIRMED THAT THE PRODUCT CONFORMED TO THE SPECIFICATIONS WHEN RELEASED ON MARCH 19, 2010. DATA WAS EXTRACTED FROM THE PUMP ON JUNE 04, 2018 PRESENTING THE FOLLOWING INFORMATION: WARNING WINDOW: HIGH VOLTAGE FEEDBACK ERROR, THIS WARNING CORRESPOND TO THE HW#8. THE PROGRAMMED FLOW RATE, VALVE-ON TIME AND COMPENSATION VALUE HAVE BEEN VERIFIED USING THE FOLLOWING MATERIALS AND ARE CONFORM TO THE EXPECTED VALUES. THE PUMP WAS VISUALLY INSPECTED PER PROCEDURE ON JULY 24, 2018 REVEALING THE FOLLOWING: 4 SUTURE LOOPS, APPROXIMATELY 20 PUNCTURES WERE OBSERVED ON THE FILLING SEPTUM, SCRATCHES WERE OBSERVED ON THE OUTER PARTS OF THE PUMP, NO NEEDLE HOLES WERE OBSERVED ON THE BOLUS SEPTUM, AND THE PUMP WAS RETURNED EMPTY. THE TOP COVER OF PUMP WAS REMOVED IN ORDER TO EXPOSE THE INSIDE OF THE ELECTRONIC CHAMBER AND TO INVESTIGATE THE ELECTRONICS. VISUAL OBSERVATION REVEALED WHITE CRYSTALS AT BOTH SIDES OF THE PIEZO BETWEEN THE PIEZO AND MEMBRANE HOLDER INDICATING THAT DRUG/SALINE GOT INTO THE ELECTRONIC CHAMBER THROUGH THE MEMBRANE. A BROKEN MEMBRANE LET DRUG ENTER INTO THE ELECTRONIC CHAMBER AND CAME IN CONTACT WITH THE PIEZO CREATING A SHORT CIRCUIT ON THE PIEZO THAT DID NOT ALLOW IT TO CHARGE ANYMORE. ROOT CAUSE ANALYSIS YIELDED THE FOLLOWING RESULTS: 1. A SMALL CRACK IN THE TI-MEMBRANE OF THE VALVE ASSEMBLY CAUSED LIQUID TO ENTER INTO THE ELECTRONIC CHAMBER AND GOT INTO CONTACT WITH THE SURFACE OF THE PIEZOELECTRIC ACTUATOR, 2. THE FUNCTIONALITY OF THE PIEZO ACTUATOR WAS AFFECTED DUE TO CONTACT WITH THE LIQUID, 3. THE REQUIRED VOLTAGE AT THE PIEZO TO OPEN THE VALVE WAS NOT REACHED WITHIN THE REQUIRED TIME INTERVAL WHICH WAS DETECTED BY THE INTERNAL RISE TIME CHECK, 4. HARDWARE FAILURE [8] WAS TRIGGERED. HOWEVER THE ROOT CAUSE OF THE TI-MEMBRANE BREAKAGE WAS NOT CLEARLY IDENTIFIED. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00502. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE DEVICE RECEIPT DATE OF (B)(6) 2018. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00502. ADDITIONAL PATIENT INFORMATION WAS REQUESTED, BUT HAS NOT YET BEEN PROVIDED. DEVICE MANUFACTURE AND EXPIRATION DATES HAVE BEEN REQUESTED BUT NOT YET RECEIVED. (B)(6). (PATIENT CODE): THE PATIENT CODE "INJURY" WAS SELECTED TO CAPTURE THE PATIENT'S WITHDRAWAL SYMPTOMS. THE PRODUCT HAS BEEN FORWARDED TO CODMAN FOR EVALUATION AND TESTING, HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MEDSTREAM PUMP ((B)(4)) WAS ALARMING WITH HARDWARE FAILURE 8 AND STOPPED WORKING AFTER A PATIENT SUFFERED A BLOW AT THE IMPLANT SITE, THE LOWER RIGHT ABDOMEN. AN EMERGENCY CALL FROM THE CLINIC WAS MADE ON (B)(6) 2018 AT 8:00AM AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT'S PUMP WAS IMMEDIATELY EMPTIED. MORPHINE 10 MG/ML; 6.5 MG/D WAS BEING ADMINISTERED THROUGH THE PUMP FOR PAIN MANAGEMENT. THE PATIENT HAD STARTED EXPERIENCING EXTREME WITHDRAWAL SYMPTOMS AND METALLIC TASTE IN THE MOUTH IN THE EARLY MORNING ON (B)(6) 2018. UPON CONSULTATION, IT WAS DETERMINED THAT THE PUMP COULD NOT BE RESET AS THERE WAS NO GUARANTEE OF FULL AND PERMANENT FUNCTION. THE PATIENT WAS ADMINISTERED IV DRUGS AND PUT ON INTENSIVE SURVEILLANCE. ON (B)(6) 2018, THE PATIENT'S MEDSTREAM PUMP WAS EXPLANTED AND A TRICUMET SIROMEDES WAS IMPLANTED. ON (B)(6) 2018, THE PATIENT WAS OCCUPIED ALL DAY DOING LUMBERING WORK AND WAS WEARING A SPECIAL CUT PROTECTION SUIT FOR LUMBERJACKS WHEN HIT IN THE ABDOMEN. THERE WAS NO VISIBLE MARK TO THE PATIENT WHERE THE PATIENT WAS STRUCK IN THE ABDOMEN. REPORTEDLY, THE PATIENT WAS FINE AFTER PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336944 MEDSTREAM PUMP 40 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDOS SARL

    Patients

    Seq Age Sex Outcome Treatment
    1