BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8329908 · Received February 11, 2019

    Report

    Report Number
    2016493-2019-00164
    Event Type
    Injury
    Date Received
    February 11, 2019
    Report Date
    January 16, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF CHANNEL ERROR CODE 13-1033-149 DURING A LEVOPHED (NOREPINEPHRINE) INFUSION WAS CONFIRMED. PHYSICAL INSPECTION OF THE DEVICE NOTED DAMAGED (SMASHED) ISOLATION RIBS ON THE RIGHT IUI CONNECTOR. THERE WERE NO OTHER DAMAGES OBSERVED. REVIEW OF THE PCU EVENT LOG SHOWWS THAT PUMP MODULE S/N (B)(4) WAS THE ONLY ACTIVE DEVICE INFUSING. AN INFUSION OF THE DRUG NOREPINEPHRINE- 8MG, 8MG/258ML (DRUGID=(B)(4)) WAS INFUSING WITH THE DOSE AT 0.12 MCG/KG/MIN (RATE=29.8841ML/H) ON 27/DEC/2018 AT 3:30PM. APPROXIMATELY 11 SECONDS INTO THE INFUSION WHEN THE DOSE WAS CHANGED, THE PUMP MODULE WAS RECORDED TO HAVE BEEN REMOVED. THIS INDUCED A ¿CHANNEL DISCONNECTED¿ ALARM ON THE PCU THAT WAS CONFIRMED. THE PUMP MODULE RECORDED SOFTWARE FAULT CODE 13-1033-149. A NEW PUMP MODULE SN (B)(4) WAS ATTACHED AFTER THE ALARM EVENT BUT THE SYSTEM WAS NO LONGER PLACED BACK IN USE ON THE DATE OF 27/DEC/2018. FUNCTIONAL TESTING PERFORMED FOUND THE DEVICES DAMAGED IUI ISOLATION RIBS DID CAUSE INTERMITTENT COMMUNICATION RELATED ISSUES. THE ROOT CAUSE FOR THE REPORTED INCIDENT OF CHANNEL ERROR 13-1033-149 IS BEING ATTRIBUTED TO DAMAGED ISOLATION RIBS ON THE RIGHT IUI CONNECTOR OF THE PUMP MODULE THAT EXHIBITED COMMUNICATION ISSUES DURING THE LOG DOWNLOADING PROCESS OF THE INVESTIGATION; HOWEVER THE ERROR EVENT COULD NOT BE REPRODUCED DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IN THE MICU WAS INTUBATED AND ON A LEVOPHED DRIP FOR HYPOTENSION. AFTER A THIRD CHANNEL WAS ADDED TO THE BRAIN/PUMP, ALL THE IV CHANNELS TURNED OFF, INCLUDING THE LEVOPHED. "CHANNEL ERROR 13-1033-149" DISPLAYED ON THE LEVOPHED CHANNEL, ALARMING AND FLASHING RED. NONE OF THE CHANNELS OR 8015 WOULD TURN BACK ON, AND THE LEVOPHED CHANNEL WOULD NOT TURN OFF, FLASHING ¿CHANNEL ERROR." AT THIS POINT THE PATIENT WAS NOT RECEIVING ANY VASOPRESSORS AND WAS BECOMING INCREASINGLY HYPOTENSIVE, WITH THE MEAN ARTERIAL PRESSURE IN THE LOW 40S. THE ENTIRE IV PUMP SETUP WAS EMERGENTLY TAKEN NEXT DOOR TO TRANSFER THE LEVOPHED AND OTHER INFUSIONS ONTO A NEW PCU AND SET OF CHANNELS AS QUICKLY AS POSSIBLE, AS THE PATIENT'S BPS CONTINUED TO DROP. THE DEFECTIVE PUMPS WERE TAKEN OUT OF CIRCULATION. ALTHOUGH REQUESTED, NO FURTHER INFORMATION OR DETAILS REGARDING THIS EVENT WERE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT IN THE MICU WAS INTUBATED AND BECOMING HYPOTENSIVE. LEVOPHED WAS INFUSING BUT AFTER A THIRD CHANNEL WAS ADDED TO THE BRAIN/PUMP, ALL THE IV CHANNELS TURNED OFF INCLUDING THE LEVOPHED. "CHANNEL ERROR 13-1033-149" DISPLAYED ON THE LEVOPHED CHANNEL, ALARMING AND FLASHING RED. NONE OF THE CHANNELS OR 8015 WOULD TURN BACK ON, AND THE LEVOPHED CHANNEL WOULD NOT TURN OFF, FLASHING ¿CHANNEL ERROR." AT THIS POINT THE PATIENT WAS NOT RECEIVING ANY VASOPRESSORS AND WAS BECOMING MORE HYPOTENSIVE, WITH THE MEAN ARTERIAL PRESSURE IN THE LOW 40S. SOMEONE HAD TO EMERGENTLY TAKE THE ENTIRE IV PUMP SETUP OUT OF THE ROOM NEXT DOOR TO TRANSFER THE LEVOPHED AND OTHER INFUSIONS ONTO A NEW PCU AND A NEW SET OF CHANNELS AS QUICKLY AS POSSIBLE, AS THE PATIENT'S BPS CONTINUED TO DROP. THE DEFECTIVE PUMPS WERE TAKEN OUT OF CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122012 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (3)8100,8015,(4)PRI TUBING, THERAPY DATE UNK