BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS LVP

    MDR report key: 9336541 · Received November 18, 2019

    Report

    Report Number
    2016493-2019-01450
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 20, 2019
    Report Date
    October 21, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO: D10 A REVIEW OF THE PCU EVENT LOG IDENTIFIED THE FOLLOWING ENTRIES IN RELATIONSHIP TO PUMP MODULE S/N 14993170 HAVING OCCURRED ON 20-OCT-2019: 21:09:58 CHANNEL OFF 21:15:35 CHANNEL SELECTED. 21:15:38 GUARDRAILS DRUGS SELECTED. 21:16:08 EXIT SELECTED. 21:16:09 CHANNEL SELECTED. 21:16:11 GUARDRAILS IV FLUIDS SELECTED. 21:16:18 EXIT SELECTED. 21:16:20 CHANNEL SELECTED. 21:16:21 GUARDRAILS DRUGS SELECTED. 21:16:53 DRUG SELECTED AND CONFIRMED. 21:17:04 INFUSION STARTED AT 5.0ML/H WITH A VTBI OF 90.0ML (PRIMARY VOLUME INFUSED = 529.088ML). 22:04:21 CHANNEL SELECTED. 22:04:52 PUMP ALARMED DOWNSTREAM OCCLUSION (PRIMARY VOLUME INFUSED = 533.043ML). 22:04:58 CHANNEL OFF IT WAS NOT POSSIBLE TO REPLICATE THE KEY SELECTIONS AND IDENTIFY THE DRUG SELECTION (INSULIN) AS AFTER THE REPORTED ISSUE AND PRIOR TO THE DEVICES BEING RETURNED FOR INVESTIGATION A NEW DATA SET WAS UPLOADED ONTO THE PCU ON (B)(6)2019 WHICH WAS ACTIVATED WHEN THE USER NEXT SELECTED NEW PATIENT = YES ON (B)(6)2019. HOWEVER THE PCU EVENT LOG REVIEW IDENTIFIED THAT AN INFUSION WAS STARTED AT 5 UNITS/ HOUR (5.0ML/H) WITH A VTBI OF 90.0ML ON THE REPORTED DATE / TIME ((B)(6)201921:00). AT THE START OF THIS INFUSION THE RECORDED VOLUME INFUSED WAS 529.088ML AND WHEN THE PUMP ALARMED FOR DOWNSTREAM OCCLUSION AND STOPPED THE INFUSION 47 MINUTES LATER THE RECORDED VOLUME INFUSED WAS 533.043ML, THEREFORE 3.955ML HAD BEEN INFUSED DURING THIS PERIOD. WITH AN ORIGINAL VTBI OF 90.0ML A REMAINING VTBI OF 86.045ML WOULD HAVE BEEN DISPLAYED, WHICH CORRESPONDS WITH THE FEEDBACK DETAILS. OPERATING AS INTENDED.

    Description of Event or Problem · 0

    THE REPORTED FEEDBACK SUGGESTS THAT THERE IS AN OVERINFUSION. AFTER 1 HR., INSULIN INFUSION BAG NOTICED THAT WAS EMPTY, THE PUMP CHECKED AND NO ALARM HEARD, IT KEEPS ON RUNNING AND THE VOLUME TO BE INFUSE SHOWS 86MLS. MD NOTIFIED AND ORDER MADE TO CHECK THE BS EVERY 30 MINUTES AND DOCUMENTED, BLOOD SUGAR WITHIN NORMAL RANGE UNTIL 0130, HOWEVER SINCE THEN PATIENT IS HAVING HYPOGLYCEMIA BS 2.9, INTERVENTION DONE AS PER DOCTOR¿S ORDER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTED FEEDBACK SUGGESTED AN OVER-INFUSION OF INSULIN OCCURRED. AN INSULIN (100 UNITS/100 ML) INFUSION WAS INITIATED ON (B)(6) 2019 AT 2100 PER HOSPITAL PROTOCOL, AT 5 UNITS/HR WITH A 5 UNIT BOLUS TAKEN FROM THE ONGOING INSULIN BAG. IT WAS NOTED THAT THE INSULIN BAG WAS COMPLETELY EMPTY AFTER 1 HOUR WITHOUT AN ALARM HEARD, AND THE INFUSION CONTINUED TO RUN WITH A VTBI (VOLUME TO BE INFUSED) OF 86ML. THE PHYSICIAN WAS NOTIFIED, AND BLOOD GLUCOSE CHECKS WERE DONE EVERY 30 MINUTES. THE BLOOD SUGAR WAS WITHIN NORMAL RANGE UNTIL 0130, HOWEVER SINCE THAT TIME THE PATIENT WAS HAVING HYPOGLYCEMIC EPISODES WITH UNSPECIFIED INTERVENTION GIVEN PER MD ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128758 ALARIS LVP PUMP, INFUSION FRN CAREFUSION ALARIS® SYSTEM LVP - 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (3) 8100, 8015,TD (B)(6) 2019| (3) 8100, 8015,TD (B)(6) 2019