BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 8255625 · Received January 16, 2019

    Report

    Report Number
    2016493-2019-00088
    Event Type
    Death
    Date Received
    January 16, 2019
    Date of Event
    December 19, 2018
    Report Date
    December 20, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRI TUBING. THE CUSTOMER¿S REPORT OF A TPN OVERINFUSION WAS NOT CONFIRMED. THE EVENT WAS REPORTED TO HAVE OCCURRED BETWEEN 4:52 PM TO 4:53 PM ON (B)(6) 2018. REVIEW OF THE PCU EVENT LOG SHOWS THAT ON (B)(6) 2018 THE PUMP MODULE WAS IN USE AND INFUSING TPN AT 20.8ML/HR. AT 11:15 AM THE USER CHANGED THE RATE TO 23ML/HR, SELECTED YES TO THE GUARDRAILS WARNING ¿RATE EXCEEDS GUARDRAILS LIMIT OF 15ML/HR. PROCEED?¿ AND STARTED THE INFUSION. AT 4:13 PM, THE DOOR WAS OPENED AND THE DEVICE ALARMED FOR FLO STOP OPEN FOR 5 SECONDS. THE DOOR WAS CLOSED AND THE INFUSION WAS RESTARTED. AT 4:52 PM, THE PRIMARY INFUSION COMPLETED AND THE DEVICE TRANSITIONED TO KVO AT THE KVO RATE OF 1ML/HR. AT 4:53 PM, THE USER CHANGED THE VTBI TO 8ML, SELECTED YES TO THE GUARDRAILS WARNING ¿RATE EXCEEDS GUARDRAILS LIMIT OF 15ML/HR. PROCEED?¿ AND STARTED THE INFUSION. AT 5:14 PM, THE PRIMARY INFUSION COMPLETED AND THE DEVICE TRANSITIONED TO KVO AT THE KVO RATE OF 1ML/HR. THE USER THEN CHANGED THE VTBI TO 115ML, SELECTED YES TO THE GUARDRAILS WARNING ¿RATE EXCEEDS GUARDRAILS LIMIT OF 15ML/HR. PROCEED?¿ AND STARTED THE INFUSION. AT 8:16 PM, THE USER CHANGED THE RATE TO 21ML/HR, SELECTED YES TO THE GUARDRAILS WARNING ¿RATE EXCEEDS GUARDRAILS LIMIT OF 15ML/HR. PROCEED?¿ AND STARTED THE INFUSION. AT 10:26 PM, THE PRIMARY INFUSION COMPLETED AND THE DEVICE TRANSITIONED TO KVO AT THE KVO RATE OF 1ML/HR. THE USER THEN CHANGED THE VTBI TO 50ML, SELECTED YES TO THE GUARDRAILS WARNING ¿RATE EXCEEDS GUARDRAILS LIMIT OF 15ML/HR. PROCEED?¿ AND STARTED THE INFUSION. AT 11:18 PM, THE INFUSION WAS PAUSED. AT 11:21 PM, THE USER PROGRAMMED A DELAY FOR 60 MINUTES AND THE DEVICE WENT INTO STANDBY. AT 11:43 PM, THE DOOR WAS OPENED AND THE DEVICE THEN ALARMED FOR FLO STOP OPEN FOR 6 SECONDS. AT 12:22 AM ON 19 DECEMBER 2018, THE DEVICE ALARMED FOR CALLBACK BEFORE INFUSION. THE USER THEN PROGRAMMED ANOTHER DELAY FOR 60 MINUTES AND THE DEVICE REMAINED IN STANDBY. AT 12:46 AM, THE USER CHANNELED THE DEVICE OFF AND THE SYSTEM WAS SHUTDOWN AND POWERED OFF. AT 10:12 AM, THE PCU WAS POWERED ON WITH 2 PUMP MODULES AND 2 SYRINGE MODULES. AT 2:43 PM, THE SYSTEM WAS SHUTDOWN AND POWERED OFF. AT 2:49 PM, THE PCU WAS POWERED ON WITH 2 PUMP MODULES AND 2 SYRINGE MODULES. THE USER THEN PROGRAMMED THE MODULE TO INFUSE INTERIM NUTRITION AT A RATE OF 11.8ML/HR WITH A VTBI OF 50ML. AT 2:50 PM, THE DEVICE ALARMED FOR CHECK IV SET. AT 2:51 PM, THE DEVICE WAS CHANNELED OFF AND THE SYSTEM WAS SHUTDOWN AND POWERED OFF. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF A TPN OVERINFUSION WAS NOT IDENTIFIED. THE PCU EVENT LOG CONTAINED NO OBVIOUS PROGRAMMING ERRORS THAT WOULD RESULT IN THE REPORTED EVENT. THERE WERE NO EVENTS AT 4:52 PM ON (B)(6) 2018. THE PUMP MODULE AND THE DISPOSABLE SET WERE NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT TPN WAS INFUSING AT 23ML/HOUR. THE NURSE HUNG A NEW TPN BAG AND APPROXIMATELY 37 SECONDS LATER IT WAS FOUND THAT 214ML OF TPN HAD INFUSED. THE BABY PASSED AWAY DURING THE INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED.

    Additional Manufacturer Narrative · 1

    BABY, AGE NOT PROVIDED. ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TPN WAS INFUSING AT 23ML/HOUR. THE NURSE HUNG A NEW TPN BAG AND APPROXIMATELY 37 SECONDS LATER IT WAS FOUND THAT 214ML OF TPN HAD INFUSED. THE BABY PASSED AWAY DURING THE INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44621 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (2)8110,8100, (2)SYR TUBING, TD (B)(6) 2018| 8015, PRI TUBING, TD (B)(6) 2018| 8015, PRI TUBING, TD (B)(6) 2018