BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 19209169 · Received April 29, 2024

    Report

    Report Number
    9616066-2024-00673
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    March 12, 2024
    Report Date
    May 10, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SET INFUSED THREE TIMES FASTER THAN INTENDED. ONE UNKNOWN ALARIS BD TUBING WAS RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS PRIMED WITH WATER AND A SECONDARY SET WAS PRIMED WITH BLUE DYE WATER. THE SETS WERE INFUSED AT A RATE OF 125 ML/HR FOR ONE HOUR INTO AN EMPTY BEAKER. NO OBSERVATION OF BACK FLOW OR OVER INFUSION WAS OBSERVED. THE CUSTOMER COMPLAINT COULD NOT BE REPLICATED. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL AND LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED

    Description of Event or Problem · 0

    NO ADDITIONAL INFO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET WAS OVER INFUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM WORD DOCUMENT: AT ~2130, THE WRITER REPLACED THE PROPOFOL TUBING AND BOTTLE AND REPROGRAMED THE VOLUME TO BE INFUSED FOR THE NEW BOTTLE. BASED ON THE INFUSION RATE OF ~25 ML/HR (FOR 60 MCG/KG/MIN WITH PT WEIGHT OF 70 KG)THE BOTTLE SHOULD HAVE LASTED ~3.5 HRS. AT ~2245, WRITER NOTICED THE BOTTLE HAD RUN EMPTY. WRITER VERIFIED THAT THE ALARIS PUMP PROGRAMMING WAS CORRECT AND DID A SITE TO SOURCE CHECK. PT IS ON LONG TERM EEG MONITORING FOR BURST SUPPRESSION. APPROX 5 MINS AFTER DISCOVERY, WRITER RECEIVED A CALL FROM THE EPILEPTOLIST ASKING IF THE SEDATIVES HAD BEEN INCREASED BECAUSE THE PT "LOOKS REALLY FLAT" ON EEG AS OF ~2132. WRITER INFORMED EPILEPTOLOGIST THAT THERE AN ERROR HAD OCCURRED WITH THE IV PUMP, WHERE DESPITE PROPER INPUT OF RATE, THE PROPOFOL INFUSED 3 TIMES FASTER THAN IT SHOULD HAVE. PROPOFOL LINE WAS TRANSFERRED TO A NEW PUMP AND CHANNEL, WITH A NEW BOTTLE (TUBING WAS KEPT THE SAME). THE PROPOFOL APPEARED TO BE INFUSING PROPERLY AFTER BEING MOVED CHANNELS. THE SAME PUMP HAD 4 CHANNELS ATTACHED, A ON THE LEFT WAS ACCESS LINE FOR INTERMITTENT MEDS, THEN ON THE RIGHT SIDE: B FOR PROPOFOL, C FOR LEVOPHED, D FOR INTERMITTENT PHENYTOIN. ALL THE OTHER CHANNELS BESIDES B APPEARED TO INFUSE DRUGS AT THE APPROPRIATE RATE AS PROGRAMMED, BEFORE AND AFTER THE CHANNEL WITH PROPOFOL WAS REMOVED. PLEASE EXPLAIN ANY CONSEQUENCES RESULTING FROM THIS EVENT (I.E., VITAL SIGN CHANGES, PATIENT RESPONSE, DELAYS, ETC.): PT IS ON LONG-TERM EEG MONITORING FOR BURST SUPPRESSION. THE EPILEPTOLIST NOTICED PT "LOOKS REALLY FLAT" ON EEG AS OF ~2132. INTERVENTIONS NEEDED DUE TO EVENT (I.E., STOPPED INFUSION, OR MEDS/BOLUS GIVEN, MONITORING, LABS, ETC.) NOTICED THERE WAS ISSUE WITH THE PUMP. THE PROPOFOL INFUSED 3 TIMES FASTER THAN IT SHOULD HAVE. PROPOFOL LINE WAS TRANSFERRED TO A NEW PUMP AND CHANNEL, WITH A NEW BOTTLE (TUBING WAS KEPT THE SAME). THE PROPOFOL APPEARED TO BE INFUSING PROPERLY AFTER BEING MOVED CHANNELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980673 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown