BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM PCU

    MDR report key: 9817841 · Received March 11, 2020

    Report

    Report Number
    2016493-2020-00338
    Event Type
    Death
    Date Received
    March 11, 2020
    Date of Event
    December 5, 2019
    Report Date
    December 6, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    Z-1520-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT THE PCU BATTERY ¿DIED¿ WHILE IT WAS IN USE WAS VERIFIED BY A REVIEW OF THE PCU EVENT LOG. THE PCU DID NOT ANNUNCIATE A LOW BATTERY ALARM (LB2) PRIOR TO THE BATTERY BEING COMPLETELY DISCHARGED. LOG ANALYSIS RESULTS: THE LOG REVIEW FOR THE ¿BATTERY DIED¿ INCIDENT BEGINS ON (B)(6) 2019 AT 9:34PM. 4 TOTAL DEVICES WERE ATTACHED TO THE PCU AND PROGRAMMED FOR INFUSIONS AT DIFFERENT TIMES. THE SYSTEM WAS RUNNING ON MAIN BATTERY POWER DURING THE ENTIRE USE UNTIL THE INCIDENT (3 HOURS, 43 MINUTES, AND 57 SECONDS). A ¿BATTERY DISCHARGED¿ EVENT WAS RECORDED IN THE LOGS AS OCCURRING ON (B)(6) 2019 AT 1:18 AM WITH 3 OUT OF THE CONNECTED 4 PUMP MODULES INFUSING. DURING THE BATTERY-DISCHARGED EVENT, THE SYSTEM DID NOT SHUTDOWN BUT WENT INTO A PAUSE STATE AS DESIGNED. THE PCU WAS PLUGGED BACK INTO AC POWER AND THE 3 PAUSED DEVICES WERE RESTARTED BY THE USER IN 3 MINUTES AND 29 SECONDS. THE ROOT CAUSE WAS ATTRIBUTED TO THE OCCURRENCE OF A ¿BATTERY DISCHARGED¿ EVENT. NOTE: THE CUSTOMER PERFORMED THEIR OWN INVESTIGATION AND REPORTED THE DEVICE ALARMED APPROPRIATELY AND THAT THEIR INVESTIGATION OUTCOME DETERMINED THIS EVENT DID NOT CONTRIBUTE TO THE PATIENTS¿ CAUSE OF DEATH.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT MEDWATCHES WERE SENT, BUT WE HAVE NOT RECEIVED COPIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCU BATTERY SHUT DOWN WHILE THE PATIENT WAS BEING TRANSFERRED. TO AN UNDESIGNATED LOCATION. THE PATIENT SUBSEQUENTLY EXPIRED "EITHER THE NEXT DAY OR A COUPLE DAYS AFTER." PER THE CUSTOMER. THE DEVICE WAS SEQUESTERED FOR AN INTERNAL INVESTIGATION, AND PER THE INVESTIGATION RESULT, IT WAS DETERMINED THAT THE DEVICE ALARMED AS EXPECTED BEFORE IT STOPPED. THE ALARM WAS FUNCTIONING PROPERLY, AND WAS NOT REQUIRED TO REMAIN SEQUESTERED AFTER THE INVESTIGATION. THE DEVICE WAS PUT BACK INTO CIRCULATION FOR USE. THE PRODUCTS (PCU, LVP MODULE/S, TUBING SET/S) WERE NOT AVAILABLE TO BE SENT IN FOR INVESTIGATION. THE CUSTOMER STATED THAT PER THE CLINICIANS INVOLVED AND THE CUSTOMER'S INVESTIGATION RESULT, THIS EVENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEATH. IT WAS DETERMINED THAT THE PATIENT'S DEATH WAS ATTRIBUTED TO THE CONDITION OF THE PATIENT, AND WAS UNRELATED TO THE DEVICE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCU BATTERY DIED WHILE IT WAS IN USE ON A PATIENT AT ONE OF SUTTER HEALTH¿S CPMC LOCATIONS WHILE THE PATIENT WAS BEING TRANSFERRED. THE PATIENT EXPIRED AFTER THE EVENT "EITHER THE NEXT DAY OR A COUPLE DAYS AFTER." THE DEVICE WAS SEQUESTERED FOR AN INTERNAL INVESTIGATION BY THE CUSTOMER. PER THE CUSTOMER'S INTERNAL INVESTIGATION RESULT, THE DEVICE ALARMED AS IT SHOULD BEFORE IT DIED, THEREFORE IT WAS FUNCTIONING PROPERLY AND DID NOT NEED TO REMAIN SEQUESTERED AFTER THE INVESTIGATION. THE DEVICE WAS PUT BACK INTO CIRCULATION FOR USE. THE PRODUCTS (PCU, LVP MODULE/S, TUBING SET/S) ARE NOT AVAILABLE TO BE SENT TO BD FOR OUR OWN INVESTIGATION. THE CUSTOMER STATED THAT PER THE CLINICIANS INVOLVED IN THE PATIENT¿S CASE AND THE CUSTOMER'S INVESTIGATION RESULT, THIS EVENT DID NOT CONTRIBUTE TO THE PATIENT¿S CAUSE OF DEATH. THE CLINICIANS DETERMINED THE PATIENT DIED FROM ATTRIBUTES OF HIS/HER CONDITION, NOT BECAUSE THE PUMP STOPPED. THE CUSTOMER VERBALIZED THAT THEY SENT VOLUNTARY AND MANDATORY MEDWATCHES TO THE FDA FOR THE EVENT. PER HOSPITAL POLICY, THE CUSTOMER WILL NOT GIVE ANY FURTHER INFORMATION TO BD SUCH AS PATIENT INFORMATION, TIME AND DATE OF EVENT, DEVICE/PRODUCT SERIAL AND LOT NUMBERS, MEDICATION INFUSING, OR DETAILS OF TRANSFER OR LEVEL OF CARE.

    Additional Manufacturer Narrative · 1

    INITIAL AWARE DATE OF THE EVENT IS (B)(6) 2019. HOWEVER, CUSTOMER PROVIDED MORE INFORMATION THAT THE DEVICE WAS IN USE ON PATIENT AT THE TIME OF THE EVENT, MAKING IT REPORTABLE, ON (B)(6) 2020. CUSTOMER PROVIDED MORE INFORMATION ON 10MAR2020 THAT PATIENT DIED SOON AFTER THE EVENT. THE REPORTED EVENT INVOLVING A PUMP MODULE(S) ¿IT WAS REPORTED THAT A PATIENT INVOLVED EVENT HAD OCCURRED AT ONE OF SUTTER HEALTH¿S CPMC LOCATIONS. A FACILITY INDIVIDUAL DID NOT SHARE ANY DETAILS ON THE EVENT, STATING THAT SUTTER HEALTH IS PERFORMING THEIR OWN INTERNAL INVESTIGATION OF THE ISSUE.¿ COULD NOT BE CONFIRMED. THE SOURCE DEVICE WAS NOT RETURNED TO ENABLE TESTING FOR THIS INVESTIGATION. THIS FILE WAS OPENED TO DOCUMENT AN EVENT THAT THE CUSTOMER REPORTED. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PCU BATTERY DIED WHILE IT WAS IN USE ON A PATIENT AT ONE OF SUTTER HEALTH¿S CPMC LOCATIONS WHILE THE PATIENT WAS BEING TRANSFERRED. THE PATIENT EXPIRED AFTER THE EVENT "EITHER THE NEXT DAY OR A COUPLE DAYS AFTER." THE DEVICE WAS SEQUESTERED FOR AN INTERNAL INVESTIGATION BY THE CUSTOMER. PER THE CUSTOMER'S INTERNAL INVESTIGATION RESULT, THE DEVICE ALARMED AS IT SHOULD BEFORE IT DIED, THEREFORE IT WAS FUNCTIONING PROPERLY AND DID NOT NEED TO REMAIN SEQUESTERED AFTER THE INVESTIGATION. THE DEVICE WAS PUT BACK INTO CIRCULATION FOR USE. THE PRODUCTS (PCU, LVP MODULE/S, TUBING SET/S) ARE NOT AVAILABLE TO BE SENT TO BD FOR OUR OWN INVESTIGATION. THE CUSTOMER STATED THAT PER THE CLINICIANS INVOLVED IN THE PATIENT¿S CASE AND THE CUSTOMER'S INVESTIGATION RESULT, THIS EVENT DID NOT CONTRIBUTE TO THE PATIENT¿S CAUSE OF DEATH. THE CLINICIANS DETERMINED THE PATIENT DIED FROM ATTRIBUTES OF HIS/HER CONDITION, NOT BECAUSE THE PUMP STOPPED. THE CUSTOMER VERBALIZED THAT THEY SENT VOLUNTARY AND MANDATORY MEDWATCHES TO THE FDA FOR THE EVENT. PER HOSPITAL POLICY, THE CUSTOMER WILL NOT GIVE ANY FURTHER INFORMATION TO BD SUCH AS PATIENT INFORMATION, TIME AND DATE OF EVENT, DEVICE/PRODUCT SERIAL AND LOT NUMBERS, MEDICATION INFUSING, OR DETAILS OF TRANSFER OR LEVEL OF CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280984 ALARIS SYSTEM PCU PUMP, INFUSION FRN CAREFUSION 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (3)8100| PRI TUBING,8100,THERAPY DATE UNKNOWN| THERAPY DATE (B)(6) 2019| PRI TUBING, 8100, THERAPY DATE UNKNOWN