BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSREAM PUMP 20 ML

    MDR report key: 7734956 · Received July 31, 2018

    Report

    Report Number
    8031062-2018-00504
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    July 1, 2018
    Report Date
    July 1, 2018
    Manufacturer
    MEDOS SARL
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00504. CONCLUSION: THE TRANSACTION LOG OF THE PUMP INTERROGATION PERFORMED ON (B)(6) 2018 SHOWED THAT THE PUMP HAD TRIGGERED A HARDWARE FAILURE [8]. THE DEVICE HISTORY RECORD (DHR) OF PRODUCT CODE 91-4200, LOT CRCDHH, SERIAL NUMBER (B)(4) WAS REVIEWED. A NON-CONFORMANCE WAS OPENED ON (B)(6) 2014, RELATED TO BATTERY ISSUE. THE MEDSTREAM PUMP MAY TRIGGER THE ¿LOW BATTERY ALARM¿ IN THE BEGINNING OF THE IMPLANTED LIFE OF THE PUMP WHICH CREATES THE IMPRESSION THAT THE BATTERY IS DEPLETED. HOWEVER, IN ALL COMPLAINTS INVESTIGATED TO DATE, THE PUMP BATTERIES CAPACITIES INVESTIGATED WERE FULL. A CAPA WAS OPENED TO RESOLVE THIS ISSUE. THERE IS NO LINK TO THE REPORTED COMPLAINT. THE PRODUCT WAS RELEASED ON APRIL 08, 2014. DATA WAS EXTRACTED FROM THE PUMP ON (B)(6) 2018 ACCORDING TO PROCEDURE REVEALING THE FOLLOWING: 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 CONFORM TO THE EXPECTED VALUES. THE PUMP WAS VISUALLY INSPECTED ON (B)(6) 2018 AND 4 SUTURE LOOPS WERE OBSERVED, APPROXIMATELY 22 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, THE PUMP WAS RETURNED EMPTY. THE TOP COVER OF PUMP WAS REMOVED IN ORDER TO LOOK AT THE INSIDE OF THE ELECTRONIC CHAMBER AND TO INVESTIGATE THE ELECTRONICS. WHITE CRYSTALS WERE FOUND AT BOTH SIDES OF THE PIEZO BETWEEN THE PIEZO AND MEMBRANE HOLDER INDICATING THAT DRUG/SALINE GOT INTO THE ELECTRONIC CHAMBER THROUGH THE MEMBRANE. DI WATER WAS INJECTED FROM THE OUTLET INTO THE PUMP YIELDING A CLEAR APPEARANCE OF WATER DROP IN THE MIDDLE OF THE MEMBRANE, CONFIRMING THE FRACTURED MEMBRANE. IT WAS CONCLUDED THAT THE BROKEN MEMBRANE LET DRUG ENTER THE ELECTRONIC CHAMBER AND CAME IN CONTACT WITH THE PIEZO. THIS CREATED A SHORT CIRCUIT ON THE PIEZO THAT DID NOT ALLOW IT TO CHARGE ANYMORE. ROOT CAUSE ANALYSIS REVEALED THAT A SMALL CRACK IN THE TI-MEMBRANE OF THE VALVE ASSEMBLY CAUSED LIQUID TO ENTER INTO THE ELECTRONIC CHAMBER AND CAME INTO CONTACT WITH THE SURFACE OF THE PIEZOELECTRIC ACTUATOR. THE FUNCTIONALITY OF THE PIEZO ACTUATOR WAS AFFECTED AS A RESULT. 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 AND THEREFORE, 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. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS FOLLOW-UP MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00504. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE DEVICE RECEIPT DATE OF SEPTEMBER 25, 2018. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION AND TESTING; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INITIAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00504. ADDITIONAL PATIENT AND INITIAL REPORTER INFORMATION WAS REQUESTED; HOWEVER, HAS NOT YET BEEN PROVIDED. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. 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 (914200/(B)(4)) HAD ALARMED IN A PATIENT ON (B)(6) 2018. THE PATIENT REPORTS THAT AT 9:11 AM THE PUMP GAVE AN ALARM AND DURING AN APPOINTMENT AT THE CLINIC IT WAS CONFIRMED. AT 9:38 AM, THE PUMP WAS READING HARDWARE (HW) ERROR 08. THE PATIENT WAS NOT SYMPTOMATIC. THE PUMP WAS STOPPED, EMPTIED, AND ALL DETAILS WERE READ OUT AND TRANSMITTED. MORPHINE 20 MG/ML, DAILY DOSE 1.4 MG/24H, WAS BEING ADMINISTERED THROUGH THE PUMP. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ORAL ADJUSTMENT OF MEDICATION UNTIL THE PUMP COULD BE EXPLANTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. THE PUMP WAS EXPLANTED ON (B)(6) 2018 AND THE PATIENT'S STATUS WAS REPORTED TO BE VERY GOOD. THE PATIENT WAS TEMPORARILY ADJUSTED WITH ORAL MEDICATION. A NEW PUMP WAS ALSO EXPECTED TO BE IMPLANTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577323 MEDSREAM PUMP 20 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDOS SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention