BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM 20DP CKV 3SS DEHP FREE

    MDR report key: 10793506 · Received November 5, 2020

    Report

    Report Number
    9616066-2020-20258
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    September 17, 2020
    Report Date
    November 24, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403227996
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THE PUMP WAS STOPPED, PROPOFOL TUBING WAS DISCONNECTED FROM THE PATIENT'S IV, AND THE PROPOFOL WAS NOTED TO CONTINUE DRIPPING FROM THE END OF THE TUBING. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2426-0007 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE WAS INVOLVED WITH A CASE OF OVERINFUSION, RESULTING IN A SERIOUS INJURY TO THE PATIENT. THE PATIENT CONTINUED BEING ADMINISTERED MEDICATION DESPITE THE PUMP BEING SWITCHED OFF, RESULTING IN AN APNEIC EPISODE. THE PATIENT EXPERIENCED SPORADIC BREATHING AND A LOSS IN BLOOD PRESSURE AS A RESULT. MEDICAL STAFF DISCONNECTED THE MEDICATION FROM THE PATIENT'S IV, CAUSING THE PATIENT'S BLOOD PRESSURE AND BREATHING TO RETURN TO NORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2426-0007 BATCH NO: UNKNOWN THE PATIENT HAD BEEN RECEIVING A PROPOFOL INFUSION DURING THE DURATION OF THE CASE. TOWARDS THE END OF THE CASE, THE INFUSION WAS STOPPED. PRIOR TO DISCONTINUING THE INFUSION, THE PATIENT WAS NOTED TO BE BREATHING SPONTANEOUSLY, AND BLOOD PRESSURE WAS RISING. 2 MINUTES LATER, THE BLOOD PRESSURE WAS NOTED TO BE LOW (70S/40S) AND PATIENT NOTED TO GO APNEIC (STOPPED SPONTANEOUSLY BREATHING). POSITIVE PRESSURE VENTILATION WAS INITIATED (THROUGH AN LMA ALREADY IN PLACE) AND VASOPRESSORS WERE ADMINISTERED TO RAISE BLOOD PRESSURE. NEXT BLOOD PRESSURE WAS AGAIN LOW, AND PATIENT REMAINED APNEIC. A FEW MINUTES LATER, WHILE STILL TREATING HYPOTENSION, THE PROPOFOL BOTTLE THAT HAD PREVIOUSLY BEEN STOPPED WAS NOTED TO BE DRIPPING AT A STEADY RATE, AND PROPOFOL WAS NOTICED TO BE GOING INTO THE IV TUBING, INTO THE PATIENT. THE PROPOFOL TUBING WAS DISCONNECTED FROM THE PATIENT'S IV, AND THE PROPOFOL WAS NOTED TO CONTINUE TO DRIP FROM THE END OF THE TUBING, DESPITE THE FACT THAT IT WAS STILL STOPPED ON THE PUMP. THE PUMP NEVER ALARMED, AND AS FAR AS A I KNOW WAS DELIVERING THE APPROPRIATE DOSE DURING THE CASE. I HAD MULTIPLE PEOPLE IN THE ROOM OBSERVE THE PUMP, AND CONFIRM THAT IT WAS STOPPED, YET STILL DRIPPING PROPOFOL. AFTER PROP WAS DISCONNECTED, PATIENT'S BLOOD PRESSURE SLOWLY BEGAN TO RETURN TO BASELINE, AND SPONTANEOUS RESPIRATIONS RETURNED ABOUT 20 MINUTES LATER. IN ALL, I SUSPECT THE PATIENT RECEIVED A 500MG BOLUS OF PROPOFOL OVER A PERIOD OF 3-4 MINUTES. PATIENT WAS EXTUBATED IN THE ROOM, AND WAS NOTED TO BE BACK TO NEUROLOGICAL BASELINE IN THE PACU 1 HOUR LATER.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE WAS INVOLVED WITH A CASE OF OVERINFUSION, RESULTING IN A SERIOUS INJURY TO THE PATIENT. THE PATIENT CONTINUED BEING ADMINISTERED MEDICATION DESPITE THE PUMP BEING SWITCHED OFF, RESULTING IN AN APNEIC EPISODE. THE PATIENT EXPERIENCED SPORADIC BREATHING AND A LOSS IN BLOOD PRESSURE AS A RESULT. MEDICAL STAFF DISCONNECTED THE MEDICATION FROM THE PATIENT'S IV, CAUSING THE PATIENT'S BLOOD PRESSURE AND BREATHING TO RETURN TO NORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(4), BATCH NO: UNKNOWN. THE PATIENT HAD BEEN RECEIVING A PROPOFOL INFUSION DURING THE DURATION OF THE CASE. TOWARDS THE END OF THE CASE, THE INFUSION WAS STOPPED. PRIOR TO DISCONTINUING THE INFUSION, THE PATIENT WAS NOTED TO BE BREATHING SPONTANEOUSLY, AND BLOOD PRESSURE WAS RISING. 2 MINUTES LATER, THE BLOOD PRESSURE WAS NOTED TO BE LOW (70S/40S) AND PATIENT NOTED TO GO APNEIC (STOPPED SPONTANEOUSLY BREATHING). POSITIVE PRESSURE VENTILATION WAS INITIATED (THROUGH AN LMA ALREADY IN PLACE) AND VASOPRESSORS WERE ADMINISTERED TO RAISE BLOOD PRESSURE. NEXT BLOOD PRESSURE WAS AGAIN LOW, AND PATIENT REMAINED APNEIC. A FEW MINUTES LATER, WHILE STILL TREATING HYPOTENSION, THE PROPOFOL BOTTLE THAT HAD PREVIOUSLY BEEN STOPPED WAS NOTED TO BE DRIPPING AT A STEADY RATE, AND PROPOFOL WAS NOTICED TO BE GOING INTO THE IV TUBING, INTO THE PATIENT. THE PROPOFOL TUBING WAS DISCONNECTED FROM THE PATIENT'S IV, AND THE PROPOFOL WAS NOTED TO CONTINUE TO DRIP FROM THE END OF THE TUBING, DESPITE THE FACT THAT IT WAS STILL STOPPED ON THE PUMP. THE PUMP NEVER ALARMED, AND AS FAR AS A I KNOW WAS DELIVERING THE APPROPRIATE DOSE DURING THE CASE. I HAD MULTIPLE PEOPLE IN THE ROOM OBSERVE THE PUMP, AND CONFIRM THAT IT WAS STOPPED, YET STILL DRIPPING PROPOFOL. AFTER PROP WAS DISCONNECTED, PATIENT'S BLOOD PRESSURE SLOWLY BEGAN TO RETURN TO BASELINE, AND SPONTANEOUS RESPIRATIONS RETURNED ABOUT 20 MINUTES LATER. IN ALL, I SUSPECT THE PATIENT RECEIVED A 500MG BOLUS OF PROPOFOL OVER A PERIOD OF 3-4 MINUTES. PATIENT WAS EXTUBATED IN THE ROOM, AND WAS NOTED TO BE BACK TO NEUROLOGICAL BASELINE IN THE PACU 1 HOUR LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258957 GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2426-0007 UNKNOWN 50885403227996

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention