BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 8691447 · Received June 12, 2019

    Report

    Report Number
    3010079947-2019-00081
    Event Type
    Injury
    Date Received
    June 12, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 15, 2019
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD, WHICH INCLUDES VERIFICATION OF ALL STEPS IN THE MANUFACTURING OF THE PUMP, VERIFICATION OF ALL FINAL TESTING PERFORMED BY/ON THE PUMP, VERIFICATION OF STERILIZATION, AND PACKAGING FOR SUBJECT PUMP WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCE'S, ISSUES OR CAPAS ASSOCIATED WITH PUMP FUNCTION. ALTHOUGH SEVERAL FOLLOW-UP ATTEMPTS WERE MADE WITH THE PHYSICIAN'S OFFICE AND PATIENT, ADDITIONAL INFORMATION WAS NOT ABLE TO BE OBTAINED REGARDING THE ALLEGED ISSUE. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    VOLUNTARY MEDWATCH REPORT #MW5107285 WAS RECEIVED THAT REPORTED: "PATIENT PRESENTED TO THE CLINIC WITH A FLOWONIX INTRATHECAL PAIN PUMP. FOLLOWING PROTOCOL BEFORE AN MRI WITH THIS PUMP, THE MEDICATION WAS REMOVED FROM THE PUMP AND 10.9 ML WAS REMOVED, WHICH WAS WITHIN NORMAL PARAMETERS OF THE EXPECTED AMOUNT, AND THE PUMP'S RESERVOIR VOLUME WAS SET TO 0 ML, AND RATE WAS SET TO RUN AT 0 ML/DAY. PATIENT CAME BACK EARLY AFTERNOON TO PUT 20 ML OF NEW MEDICATION BACK INTO THE PUMP. PUMP WAS ACCESSED AND A 15 SECOND PULL BACK AND 2 ML OF FLUID WAS REMOVED, AFTER A SECOND PULL BACK 1 ML WAS REMOVED, AND AFTER A 3RD PULL BACK 1 ML WAS REMOVED. AFTER A FULL 1 MINUTE ASPIRATION 4.7 ML WAS REMOVED. FOR SAFETY, 20 ML OF NORMAL SALINE WAS PUT BACK IN THE PUMP AND PATIENT'S RATE WAS SET BACK TO THE ORIGINAL SETTING, AND WE MONITOR PATIENT. [THE PATIENT] BEGAN HAVING OPIOID WITHDRAWAL SYMPTOMS: N/V, SWEATING AND HIS PULSE OX AT ROOM AIR WAS 88% WITH NO HISTORY OF LUNG ISSUES. WE SENT PATIENT TO THE ER. FLOWONIX RECOMMENDED TAKING THE NACL OUT DUE TO A POTENTIAL FAULTY VALVE FOLLOWING THE MRI BUT WE HAD ALREADY D/C THE PATIENT TO ER. AFTER PATIENT'S ER VISIT, [THE PATIENT] CAME BACK TO OUR CLINIC THAT EVENING. ZERO (0) ML WAS IN THE RESERVOIR WHEN WE HAD PLACED 20 ML OF NORMAL SALINE WITHIN A FEW HOURS. UPON ASPIRATION WITH A 1 MINUTE PULL BACK 1 ML OF FLUID WAS NOTED AND AFTER ANOTHER 1 MINUTE ASPIRATION 2 ML OF FLUID WAS NOTED. PATIENT WAS REFERRED TO A SURGEON TO HAVE THIS PUMP REMOVED DUE TO A FAULTY VALVE POST MRI. THIS PATIENT HAD THE FLOWONIX INTRATHECAL PUMP FOR A TOTAL OF 6 YEARS. FLOWONIX GENERALLY LAST 10 YEARS BUT CAN LAST LONGER. FDA SAFETY REPORT ID # (B)(4)."

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ADDITIONAL VOLUME WAS REMOVED FROM THE PUMP POST-MRI. THE PUMP WAS REFILLED WITH SALINE AND THE PATIENT SUBSEQUENTLY HAD A DROP IN THEIR VITAL SIGNS. THE PATIENT WAS SENT TO THE ER FOR MONITORING. PATIENT WAS SUBSEQUENTLY RELEASED FROM THE ER AND SENT BACK TO THE CLINIC. THE SALINE WAS REMOVED FROM THE PUMP AND ADDITIONAL MINIMAL VOLUME OF FLUID WAS REMOVED ALONG WITH THE SALINE. THE VOLUME WAS TESTED WITH A GLUCOMETER AND THE PHYSICIAN CONCLUDED THAT THE FLUID WAS CEREBROSPINAL FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483524 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| R| H