BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA REFILL KIT

    MDR report key: 10406642 · Received August 14, 2020

    Report

    Report Number
    3010079947-2020-00267
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 21, 2020
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020143
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MFR SITE (SECOND ADDRESS). PROVEN PROCESS MEDICAL DEVICES OPENED AND COMPLETED PVCR-0820-025 TO ADDRESS THIS ISSUE. THROUGH THE INVESTIGATION, IT WAS CONFIRMED THAT THE EXTENSION TUBING IN THE REFILL KIT WAS DETERMINED TO BE OCCLUDED BY SOLVENT WHERE THE LUER FITTING IS SOLVENT BONDED TO THE TUBING SET. PROVEN PROCESS MEDICAL DEVICES HAS INFORMED FLOWONIX THAT ADDITIONAL SAMPLES OF OCCLUDED EXTENSION SETS ARE NO LONGER REQUIRED FOR COMPLETION OF THE INVESTIGATION. THEREFORE, INVESTIGATION WAS PERFORMED WITHOUT RETURN OF THIS PRODUCT. SUPPLEMENTAL MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED. INTERNAL COMPLAINT NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    PER MEDICAL REVIEW OF THIS EVENT, CONSULTANT MD CONCLUDED THAT THIS REPORT IS INDICATIVE OF USER ERROR. PER THE REVIEW, "IF THE FIRST TUBING WAS KINKED OR THE NEEDLE OCCLUDED OR NOT POSITIONED CORRECTLY, THE ATTEMPTED REFILL SHOULD HAVE BEEN ABANDONED. THE KINKED TUBING DOES NOT EXPLAIN THE ADVERSE EVENT WHICH WAS CLEARLY INJECTION OF SUBQ FENTANYL. IF THE NEEDLE WAS CONFIRMED TO HAVE PASSED THE SEPTUM AND NO FLUID COULD BE ASPIRATED, THE PROCEDURE SHOULD HAVE BEEN ABANDONED." ALTHOUGH THE FIRST REFILL KIT HAD AN ALLEGED OCCLUSION, THE POTENTIAL POCKET FILL THAT OCCURRED IS NOT CONSIDERED TO BE RELATED. IF THERE WAS TRULY AN OCCLUSION IN THE TUBING, A POCKET FILL WOULD NOT BE POSSIBLE AS NO MEDICATION COULD BE ADVANCED TO THE PUMP AND/OR POCKET. FURTHERMORE, CONTINUOUS ATTEMPTS TO UTILIZE THE ALLEGEDLY MALFUNCTIONING REFILL KIT SHOULD NOT HAVE TAKEN PLACE. UPON INITIAL RESISTANCE, AS INDICATED BY THE MEDICAL REVIEW, THE PROCEDURE SHOULD HAVE BEEN STOPPED AND RESUMED ONLY ONCE A NEW REFILL KIT COULD BE USED. PER FOLLOW-UP, IT WAS CONFIRMED THAT NO FLUOROSCOPY OR ULTRASOUND GUIDANCE WAS USED TO CONFIRM NEEDLE PLACEMENT. PER CONSULTANT MD, "IF THE NEEDLE WAS CONFIRMED TO HAVE PASSED THE SEPTUM AND NO FLUID COULD BE ASPIRATED, THE PROCEDURE SHOULD HAVE BEEN ABANDONED." FURTHER INVESTIGATION IS NECESSARY TO EVALUATE THE ALLEGED OCCLUSION. PENDING RETURN OF THIS PRODUCT. THE RESULTS OF THAT INVESTIGATION, ALBEIT UNRELATED TO THE PATIENT EFFECTS, WILL BE COMMUNICATED IN A SUPPLEMENTAL MDR ONCE COMPLETED. (B)(4).

    Description of Event or Problem · 1

    RECEIVED VOLUNTARY MEDWATCH, USER FACILITY REPORT # (B)(4), FORWARDED FROM AGENT WHO HAD RECEIVED THE REPORT FROM THE HEALTH PROFESSIONAL. MEDWATCH STATES, "RN ACCESSED PAIN PUMP FOR REFILL PROCEDURE. EXPECTED 6.2 ML RETURN OF FENTANYL FROM PROMETRA II PUMP. NO RETURN NOTED BUT CLEARLY ACCESSED CORRECTLY. 2ND RN EVALUATED. NEEDLE PULLED BACK AND REASSESSED PUMP. NO RETURN OF FENTANYL AGAIN. NEW REFILL KIT UTILIZED TO ACCESS PAIN PUMP. PUMP ACCESSED EASILY. ESTIMATED 4.8ML OF FENTANYL RETURNED INTO SYRINGE. REFILL PROCESS COMPLETED. WITHIN 5-8 MINUTES OF INITIAL ACCESS, PATIENT DEMONSTRATED DECREASING LEVEL OF CONSCIOUSNESS. PATIENT ASSISTED TO LIE DOWN ON EXAM TABLE. PATIENT NOTED TO BE DIAPHORETIC. EMERGENCY RESPONSE ENGAGED. PATIENT NOT RESPONSIVE TO STERNAL RUB, OXYGEN SATURATION DOWN TO 70'S, AND SPONTANEOUS RESPIRATIONS DECLINING TO AGONAL BREATHS. ASSISTED VENTILATION WITH BAG/MASK VENTILATION WITH 100% SUPPLEMENTAL OXYGEN. BLOOD GLUCOSE CHECKED AND WITHIN NORMAL RANGES. PUPILS PINPOINT. IV STARTED AND NARCAN ADMINISTERED. PATIENT RESPONDED WELL AFTER DOSE OF NARCAN. FULLY AWAKE AND ORIENTED. PHYSICIAN EVALUATED PUMP ACCESS SITE AND WAS NOT ABLE TO PALPATE ANY OBVIOUS SUBCUTANEOUS POCKET FILL. PHYSICIAN REASSESSED PUMP ONCE PATIENT WAS STABLE AND WAS ABLE TO ASPIRATE APPROPRIATELY MEDICATION INSTILLED BY RN. SUSPECTED EXTRAVASATION OF HIGH DOSE FENTANYL (4500MCG/ML) WITH EST. 1.2ML UNACCOUNTED FOR FROM PUMP EVALUATION OF RESERVOIR VOLUMES. PATIENT WAS TAKEN PROMPTLY TO THE EMERGENCY DEPARTMENT FOR FURTHER EVALUATION AND MONITORING. PATIENT REQUIRED AN ADDITIONAL DOSE OF NARCAN. PATIENT WAS RELEASED HOME AFTER 2 HOURS OF OBSERVATION & REMAINING STABLE AND ALERT. PRIOR TO EVENT, PATIENT WAS ALERT, ORIENTED, AND AMBULATORY INTO CLINIC FOR PUMP REFILL PROCEDURE. AFTER COMPLETION OF REFILL AND STABILIZATION OF PATIENT, TUBING FROM ORIGINAL REFILL KIT WAS ASSESSED BY PHYSICIAN. ATTEMPTED TO FLUSH TUBING, AND FOUND TUBING TO BE OCCLUDED IN THE REFILL KIT, THUS RESULTING IN THE INABILITY TO EXTRACT REMAINING MEDICATION AFTER ACCESSING PUMP. SEQUESTERED TUBING AND BOX FROM KIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873438 PROMETRA REFILL KIT FLOWONIX PROMETRA PUMP REFILL KIT LKK FLOWONIX MEDICAL, INC. 11825 26330 00810335020143

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention