BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 14885200 · Received July 1, 2022

    Report

    Report Number
    2016493-2022-159244
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 14, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE PC UNIT WITH FOUR PUMP MODULES WAS ATTACHED TO AN IV POLE WITH A NOTE READING, "DO NOT USE". WHILE THE CLINICIAN WAS WAITING TO PROVIDE AN IN-SERVICE, THEY ASSESSED THE PUMP MODULES FOR DAMAGE. THERE WAS NO APPARENT DAMAGE TO IUI CONNECTORS, NO CORROSION. DOOR, LATCH, SEAR, AND THE PLATEN LOOKED FINE. AFTER THEIR IN-SERVICE, THEY ASKED THE NURSE WHY THE DEVICE HAD THE "DO NOT USE" SIGN ATTACHED. THE NURSE PROCEEDED TO EXPLAIN THERE WAS A FREE FLOW OCCURRENCE OF NOREPINEPHRINE. THE CLINICIAN LOCATED THE ATTENDING NURSES INVOLVED WHO EXPLAINED: PATIENT'S BLOOD PRESSURE - 60/30. A FLUID BOLUS ORDERED TO BE ADMINISTERED VIA TWO SEPARATE LVPS AT A RATE OF 999. EACH NOREPINEPHRINE ALSO ORDERED 4 MG/250; DOSE 3 MCG/MIN. NURSE STATED SHE HUNG THE BAG OF NOREPHINEPHRINE, PRIMED THE MED THROUGH DEDICATED SET, LOADED THE TUBING AND ATTACHED TO PATIENT. THE NURSES DID NOT YET PROGRAM THE MED. WHEN THEY PUSHED THE CHANNEL SELECT BUTTON TO PROGRAM, THE INFUSION STARED AT 999. THE NURSE STATED THEY STOPPED THE MED IMMEDIATELY. PATIENT'S BLOOD PRESSURE ROSE TO 240/100. THEY WERE ABLE TO STABILIZE THE PATIENT WITHIN TEN MINUTES. THE DEVICE WAS NOT TAKEN OUT OF SERVICE AFTER THIS INCIDENT. IT WAS USED BY A THIRD NURSE, WHO WAS NOT WORKING DURING THE TIME THE CLINICIAN WAS COLLECTING INFORMATION. THE OTHER TWO NURSES STATED THE THIRD NURSE ATTEMPTED TO ADMINISTER "SOMETHING ELSE", AND THE SAME THING OCCURRED. THE INFUSION STARTED AT 999. THE CLINICIAN DOES NOT HAVE SPECIFIC DETAILS ABOUT THE SECOND INCIDENT BECAUSE THE THIRD NURSE WAS NOT WORKING AND THE OTHER TWO NURSES COULD NOT PROVIDE MORE SPECIFIC INFORMATION. THE NURSES STATED WHEN THE DEVICE WAS USED FOR THE PATIENT, THERE WAS ONLY THREE LVPS ATTACHED TO THE PCU. AT THE TIME IT WAS DISCOVERED A FOURTH MODULE HAD BEEN ADDED TO THE SET UP. THE NURSES DO NOT KNOW WHO MIGHT HAVE DONE ATTACHED THE MODULE OR WHY. THERE WAS PATIENT INVOLVEMENT BUT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279660 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015| 8100 (3)