BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 8890315 · Received August 13, 2019

    Report

    Report Number
    2016493-2019-00967
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    June 20, 2019
    Report Date
    July 15, 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
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT THAT THE KETAMINE INFUSION BAG WAS FOUND EMPTY AFTER 2 HOURS WAS NOT CONFIRMED IN THE LOG. THE CUSTOMER DID NOT RETURN THE SOURCE PUMP MODULE FOR THIS INVESTIGATION. THE PCU EVENT LOG AND THE DATASET WERE PROVIDED. THE CUSTOMER¿S STATEMENT ¿A BROKEN PART IN THE PUMP WAS IDENTIFIED THAT PLACED PRESSURE AGAINST THE TUBING TO CONTROL THE RATE/FLOW OF MEDICATION DELIVERED¿ WAS BELIEVED TO BE THE PLATEN ASSEMBLY. SINCE THE DEVICE WAS NOT RETURNED, AND NO PICTURE PROVIDED, THIS CANNOT BE CONFIRMED. THE REVIEW OF THE PCU EVENT LOG IDENTIFIED AN INFUSION OF KETAMINE (DRUG ID 275) ON (B)(6) 2019. THE LOGS DID NOT IDENTIFY ANY OBVIOUS PROGRAMMING ERRORS. THE SOURCE PUMP MODULE INFUSED THE MEDICATION KETAMINE FOR APPROXIMATELY 1.5 HOURS. THE SOURCE DEVICE WAS THEN CHANNELED OFF. DURING THE KETAMINE INFUSION THERE WERE NO ALARMS. THE INFUSION NEVER RECEIVED ANY TITRATION DOSE CHANGES. THE CUSTOMER DID NOT RETURN THE INCIDENT ADMINISTRATION SET FOR THIS INVESTIGATION. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "KETAMINE INFUSION IV THROUGH ALARIS PUMP INFUSED OVER A 2 HOUR PERIOD PUMP WAS PROGRAMMED CORRECTLY PT DEVELOPED HYPOTENSION THAT RESOLVED QUICKLY WITHOUT INTERVENTION PUMP WAS FOUND TO HAVE A BROKEN PART IN THE CHANNEL WHICH WOULD HAVE REGULATED THE FLOW RATE FDA SAFETY REPORT ID# (B)(4)." THE CUSTOMER REPORTED ON 6-20-19 AT 1107 AN INFUSION WAS INITIATED VIA PERIPHERAL IV , KETAMINE (500 ML) PROGRAMMED AT 0.05 MG/KG/HR, AND TITRATED FROM 0.05MG/KG/HR TO 2 MG/KG/HR (RATE: 3.2ML/HR ¿ 128.8 ML/HR.) .APPROXIMATELY 2HRS AFTER THE START OF THE INFUSION, THE RN NOTICED THAT DEVICE ALARMED AND FOUND THE BAG EMPTIED, THERE WAS NO LEAKS NOTED. THE RN STATED THAT THE PATIENT BLOOD PRESSURES RECORDED ON THE EHR PRE EVENT /POST WERE: 123/89 (1100), 128/86 (1130), 110/81 (1152), 100/83 (1200), 148/91 (1230), 111/79 (1300), 116/72 (1330). OTHER INFUSIONS AT THE TIME OF THE EVENT; SODIUM BICARBONATE 150 MEQ/D5W 1000 ML INFUSION AT 150 ML/HR. AND NOREPINEPHRINE 4,000 MCG/ D5W 250 ML INFUSION 1.9 ¿ 112.5 ML/HR. AFTER INSPECTION BY BIOMED, A BROKEN PART IN THE PUMP WAS IDENTIFIED THAT PLACED PRESSURE AGAINST THE TUBING TO CONTROL THE RATE/FLOW OF MEDICATION DELIVERED. THE CUSTOMER FELT THIS WAS THE CAUSE OF THE OVER INFUSION EVENT.

    Additional Manufacturer Narrative · 1

    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

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "KETAMINE INFUSION IV THROUGH ALARIS PUMP INFUSED OVER A 2 HOUR PERIOD PUMP WAS PROGRAMMED CORRECTLY PT DEVELOPED HYPOTENSION THAT RESOLVED QUICKLY WITHOUT INTERVENTION PUMP WAS FOUND TO HAVE A BROKEN PART IN THE CHANNEL WHICH WOULD HAVE REGULATED THE FLOW RATE FDA SAFETY REPORT ID# (B)(4)." THE CUSTOMER REPORTED A KETAMINE (500 ML) INFUSION INITIATED AT 0.05 MG/KG/HR, AND TITRATED FROM 0.05MG/KG/HR TO 2 MG/KG/HR (RATE: 3.2ML/HR ¿ 128.8 ML/HR.) INFUSED TOO RAPIDLY AND FINISHED EARLIER THAN EXPECTED. THE PUMP WAS VERIFIED TO BE PROGRAMMED CORRECTLY, AND THERE WERE NO ALARMS, HOWEVER THE IV BAG WAS NOTED TO BE EMPTY. AFTER INSPECTION BY BIOMED, A BROKEN PART IN THE PUMP WAS IDENTIFIED THAT PLACED PRESSURE AGAINST THE TUBING TO CONTROL THE RATE/FLOW OF MEDICATION DELIVERED. THE CUSTOMER FELT THIS WAS THE CAUSE OF THE OVER INFUSION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683163 ALARIS® PUMP MODULE INFUSION PUMP FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other 8100, 8100, 8015,(3) PRI TUBING, TD: (B)(6) 2019.