BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PUMP 40 ML

    MDR report key: 6991184 · Received October 31, 2017

    Report

    Report Number
    8031062-2017-00006
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    August 10, 2017
    Report Date
    August 10, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2017-00006. DEVICE MANUFACTURE DATE: UPDATED TO INCLUDE DEVICE MANUFACTURE DATE: (B)(6) 2014. CONCLUSION: THE DEVICE WAS RECEIVED FOR ANALYSIS ON SEPTEMBER 05, 2017. ON SITE TECHNICAL SUPPORT WAS REPORTED ON AUGUST 10, 2017; SEVERAL PUMP INTERROGATIONS WERE PERFORMED WITH TWO DIFFERENT CONTROL UNITS (ONE OF THE PHYSICIAN'S CONTROL UNITS AND ONE OF THE CLINICAL SUPPORT MANAGER'S CONTROL UNITS). A CROSS CHECK CONFIRMED THAT BOTH CONTROL UNITS WERE SUCCESSFULLY COMMUNICATING WITH ANOTHER PUMP. THE COMMUNICATION ENVIRONMENT WAS ALSO CHECKED FOR INTERFERENCE. AS A PREVENTATIVE MEASURE, THE PUMP RESERVOIR WAS EMPTIED AS THERE WAS NO COMMUNICATION WITH THE PUMP. A RECOMMENDATION WAS MADE TO PUT THE PATIENT ON ORAL MEDICATION AND PUMP REPLACEMENT WAS SCHEDULED FOR A DATE WITHIN THE FOLLOWING TWO WEEKS. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THAT THE DEVICE CONFORMED TO SPECIFICATIONS UPON RELEASE. DATA COULD NOT BE EXTRACTED FROM THE PUMP AS IT WAS UNABLE TO COMMUNICATE WITH THE CONTROL UNIT. THE REPORTED EVENT OF "COMMUNICATION ERROR" WAS CONFIRMED. UPON VISUAL INSPECTION, THERE WERE FOUR SUTURE LOOPS NOTED, APPROXIMATELY TEN PUNCTURES OBSERVED ON THE FILLING SEPTUM, NO SCRATCHES FOUND TO THE TITAN PART, AND APPROXIMATELY FOUR HOLES ON THE BOLUS SEPTUM. THE PUMP WAS STEAM STERILIZED AND BUTANE WAS EXTRACTED FROM THE PUMP BUTANE CHAMBER. THE TOP COVER OF THE PUMP WAS CAREFULLY REMOVED IN ORDER TO AVOID DETACHMENT OF SMALL TITANIUM CHIPS FROM THE COVER DURING MACHINING, ALLOWING ACCESS TO THE ELECTRONIC CHAMBER. VISUAL INSPECTION OF THE PUMP ELECTRONIC CHAMBER WAS CONDUCTED, UNDER BINOCULAR, REVEALING WHITE CRYSTALS IN SEVERAL PARTS OF THE ELECTRONIC CHAMBER. IT IS SUSPECTED THAT THE WHITE CRYSTALS WERE TRACES OF DRUG. THE PIEZO WAS REMOVED IN ORDER TO FIND THE SOURCE OF DRUG TRACES IN THE ELECTRONIC CHAMBER. THE PIEZO WAS CLEAN, HOWEVER, WHITE CRYSTALS WERE FOUND CLOSE TO THE MEMBRANE UNDER THE PIEZOELECTRIC ACTUATOR, INDICATING THAT THE DRUG CRYSTALS WERE COMING THROUGH THE MEMBRANE. IN ORDER TO DETERMINE WHETHER OR NOT THE MEMBRANE WAS PERMEABLE, DISTILLED WATER WAS INJECTED FROM THE PUMP OUTLET INTO THE PUMP. A CLEAR DROP OF WATER WAS NOTED IN THE MIDDLE OF THE MEMBRANE, CONFIRMING THAT THERE WAS A CRACK IN THE MEMBRANE ALLOWING THE DRUG TO LEAK INTO THE ELECTRONIC CHAMBER. THE ROOT CAUSE FOR THE REPORTED FAILURE IS THE CRACK NOTED TO THE MEMBRANE UNDER THE PIEZOELECTRIC ACTUATOR. THE CRACK BREAKS THE TITANIUM MEMBRANE AND ALLOWS THE DRUG TO LEAK FROM THE FLUIDIC PATH INTO THE ELECTRONIC CHAMBER. THE FUNCTIONALITY OF THE PUMP WAS AFFECTED DUE TO THE CONTACT BETWEEN THE ELECTRONIC CHAMBER AND THE DRUG. THIS EXPLAINS THE ALARM HEARD BY THE PATIENT AND THE CONSEQUENT COMMUNICATION FAILURE. THIS TREND WILL BE MONITORED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    AN INITIAL MDR WAS SUBMITTED BY CODMAN NEUROSURGICAL, PRIOR TO THEIR DIVESTITURE TO INTEGRA LIFE SCIENCES ON (B)(6) 2017, UNDER MFR REPORT #1226348 - 2017 - 10634. THIS REPORT WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2017-00006. (B)(4). 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

    PATIENT HAD HEARD A PUMP ALARM ON (B)(6) 2017 AND WENT TO THE HOSPITAL ON (B)(6) 2017 FOR CHECKING THE PUMP. NO ALARM COULD BE HEARD. INTERROGATION WITH THE PUMP FAILED. COMMUNICATION ERROR. A CROSS CHECK WITH A DEMO PUMP AND AN OTHER CU SHOWS THAT THE COMMUNICATION WITH THE IMPLANTED PUMP FAILED BUT THE CU´S ARE WORKING FINE. FURTHER INFORMATION RECEIVED FROM (B)(6) REVEALED: DUE TO THE INCREASING DYSTONIA WE ARE SURE THAT THE DRUG DELIVERY WAS STOPPED. AS INTERROGATION WITH THE PUMP ((B)(4)) FAILED WITH DIFFERENT CU WE CAN BE SURE THAT THERE IS A MALFUNCTION OF THE PUMP. THE PATIENT GOT ORAL MEDICATION. AS THE ORAL THERAPY WAS NOT SATISFYING THE PATIENT GOT A NEW PUMP TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770754 MEDSTREAM PUMP 40 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1