BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 5053989 · Received September 3, 2015

    Report

    Report Number
    2016493-2015-00625
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    June 18, 2015
    Report Date
    July 30, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF THE PAUSE FUNCTION NOT BEING EMPLOYED WAS NOT DEFINITIVELY CONFIRMED. REVIEW OF THE PCU EVENT LOGS SHOWED THAT ON (B)(6) 2015 AT 3:18 PM THE USER PAUSED AN INFUSION OF "IV FLUIDS" (DRUG ID=1) ON PUMP MODULE S/N (B)(4) FOR 4 MINUTES THEN RESTARTED THE INFUSION. A SHORT TIME LATER THE USER PAUSED THE IV FLUID INFUSION FOR 2 MORE MINUTES. THREE OTHER INFUSIONS WERE FOUND TO BE ACTIVELY INFUSING AROUND THE TIME OF THE EVENT, HOWEVER THE EVENT LOGS DID NOT CONFIRM THAT ANY OF THE OTHER DEVICES WERE PAUSED AROUND THE TIME OF THE REPORTED EVENT. THE ROOT CAUSE WAS NOT IDENTIFIED. NO DEVICE WAS RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF THE PAUSE FUNCTION NOT BEING EMPLOYED OR NOT WORKING WHEN USED WAS NOT CONFIRMED. FOLLOWING PRIOR REVIEW OF THE ASSOCIATED PCU EVENT LOG WHICH CONFIRMED THE INFUSION HAD BEEN PAUSED TWO DIFFERENT TIMES DURING THE TIME PERIOD IN QUESTION, THE DEVICE WAS RECEIVED FOR FURTHER INVESTIGATION. PHYSICAL INSPECTION NOTED THE DEVICE TO BE IN GOOD CONDITION AND NO ISSUES RELATED TO THE REPORTED PAUSE KEY ISSUE WERE OBSERVED. THE DEVICE PASSED KEYPAD TESTING WITH NO ISSUES NOTED. REPEATED TEST INFUSIONS PROGRAMMED USING THE SOURCE PUMP MODULE AND THE PAUSE KEY FOUND THE DEVICE TO BE FULLY FUNCTIONAL AFTER EACH KEYPRESS WITH NO ISSUES NOTED. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE PASSED TESTING WITH NO ISSUES NOTED. THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT OF THE PAUSE FUNCTION NOT BEING EMPLOYED WAS NOT DETERMINED. THOROUGH TESTING WAS PERFORMED AND NO DEVICE MALFUNCTION IS BELIEVED TO HAVE OCCURRED.

    Additional Manufacturer Narrative · 1

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE HIGH GLUCOSE LAB RESULT THAT MAY HAVE OCCURRED BECAUSE THE PUMP WAS NOT PAUSED DURING THE LAB DRAW, ALTHOUGH THE NURSE BELIEVES THAT SHE DID PAUSE THE PUMP. THE NURSE ALLEGED THAT "SOMETIMES THE PAUSE DOES NOT WORK." INITIALLY, THERE WAS NO REPORT OF PATIENT HARM RELATING TO THIS EVENT AS NO TREATMENT WAS RENDERED BASED ON THE GLUCOSE LEVEL. IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT PASSED AWAY ON THE DAY OF THE EVENT DUE TO NUMEROUS CRITICAL ILLNESSES. THE PATIENT HAD BEEN RESUSCITATED SEVERAL TIMES THAT DAY AND THE CUSTOMER DOES NOT BELIEVE ANY PUMP FAILURE WAS RESPONSIBLE FOR THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584982 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death