BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6012275 · Received October 7, 2016

    Report

    Report Number
    2016493-2016-00753
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 11, 2016
    Report Date
    September 16, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S EXPERIENCE OF A FREE FLOW OF A PROPOFOL DRIP WAS NEITHER CONFIRMED NOR REPLICATED. THE PUMP MODULE WAS RECEIVED IN OVERALL FAIR CONDITION WITH THE INSTRUMENT SEAL INTACT AND MINOR CHIPPING AND CRACKING ON THE REAR CASE. THE LOWER DOOR HINGE WAS CRACKED AND THE LATCH/SEAR ASSEMBLY WAS OBSERVED TO BE THIRD-PARTY. ONLY THE PUMP MODULE AND ITS LOGS WERE RECEIVED FOR INVESTIGATION; ONLY LIMITED INFORMATION CAN BE OBTAINED FROM THE MODULE¿S EVENT LOG, AND THE MEDICATION AND PROFILE IN USE CANNOT BE IDENTIFIED. THE LOG SHOWS THAT AT 2:04 AM ON (B)(6) 2016 THE DEVICE WAS PROGRAMMED TO INFUSE AT 3.306 ML/HR WITH A VTBI OF 85 ML. THE DEVICE WAS CHANNELED OFF AT 2:21 AM. FUNCTIONAL TESTING PERFORMED FOUND THE PUMP MODULE TO BE DELIVERING FLUID WITHIN SPECIFICATION. TESTING NOTED THAT THE CRACKED DOOR HINGE HAD NO FUNCTIONAL EFFECT ON DEVICE PERFORMANCE; THERE IS ENOUGH OF THE MATERIAL TO KEEP THE DOOR AND PLATEN IN PLACE WHEN CLOSED, AND FREE-FLOW WAS NOT REPLICATED DURING TESTING. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF A FREE FLOW OF A PROPOFOL DRIP WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDWATCH INFORMATION RECEIVED.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE MEDWATCH REPORT FROM THE CUSTOMER WHICH STATES, "FREE FLOW OF PROPOFOL DRIP. PATIENT INTUBATED IN ER FOR AIRWAY PROTECTION. PROPOFOL STARTED AT 5MCG/KG/MIN. WHILE TURNING PATIENT A FEW MINUTES LATER 2 OTHER RNS NOTICED THAT BOTTLE WAS MOSTLY EMPTY AND WAS DRIPPING FAST. IMMEDIATELY PAUSED DRIP. LOOKED AT PROGRAM AND VERIFIED THAT CHANNEL WAS PROGRAMMED CORRECTLY AT 5MCG/KG/MIN. ATTEMPTED TO VOLUME OUT CHANNEL. PUMP BRAIN READ VOLUME INFUSED FOR THIS CHANNEL WAS 0.9ML. EVEN THOUGH WHEN MANUALLY EMPTIED TUBING AND BOTTLE THERE WAS ONLY 30ML LEFT (100ML IN ENTIRE BOTTLE). BP TAKEN IMMEDIATELY AND WAS 66/40. THE 1L BOLUS GIVEN WITH FREQUENT BP CHECKS EVERY 2 MINUTES. PATIENT RESPONDED TO BOLUS. BP AT END OF 1L BOLUS 94/56. CHANNEL TAGGED AS DAMAGED. INSPECTION OF THE DEVICE REVEALED A CRACK OF THE OUTER DOOR HINGE. WE WERE PREVIOUSLY AWARE OF ALARIS HAVING ISSUES WITH FREE FLOW WHEN THE INNER HINGE IS CRACKED, BUT THIS INVOLVED THE OUTER DOOR. AN ALERT WAS SENT OUT TO NURSING TO EXAMINE AND SECURE ALL OTHER PUMPS WITH THIS DEFECT. TO DATE, 6 OTHER PUMPS WITH OUTER HINGE CRACKS HAVE BEEN IDENTIFIED (7 ALTOGETHER). 5 OF THE PUMPS WITH DEFECTIVE CASING OF THE OUTER HINGE WERE MANUFACTURED IN 2006, 1 PUMP WAS FROM 2011 AND THE OTHER PUMP WAS FROM 2013."

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE MEDWATCH REPORT FROM THE CUSTOMER WHICH STATES, "FREE FLOW OF PROPOFOL DRIP. PATIENT INTUBATED IN ER FOR AIRWAY PROTECTION. PROPOFOL STARTED AT 5MCG/KG/MIN. WHILE TURNING PATIENT A FEW MINUTES LATER 2 OTHER RNS NOTICED THAT BOTTLE WAS MOSTLY EMPTY AND WAS DRIPPING FAST. IMMEDIATELY PAUSED DRIP. LOOKED AT PROGRAM AND VERIFIED THAT CHANNEL WAS PROGRAMMED CORRECTLY AT 5MCG/KG/MIN. ATTEMPTED TO VOLUME OUT CHANNEL. PUMP BRAIN READ VOLUME INFUSED FOR THIS CHANNEL WAS 0.9ML. EVEN THOUGH WHEN MANUALLY EMPTIED TUBING AND BOTTLE THERE WAS ONLY 30ML LEFT (100ML IN ENTIRE BOTTLE). BP TAKEN IMMEDIATELY AND WAS 66/40. 1L BOLUS GIVEN WITH FREQUENT BP CHECKS EVERY 2 MINUTES. PATIENT RESPONDED TO BOLUS. BP AT END OF 1L BOLUS 94/56. CHANNEL TAGGED AS DAMAGED. INSPECTION OF THE DEVICE REVEALED A CRACK OF THE OUTER DOOR HINGE. WE WERE PREVIOUSLY AWARE OF ALARIS HAVING ISSUES WITH FREE FLOW WHEN THE INNER HINGE IS CRACKED, BUT THIS INVOLVED THE OUTER DOOR. AN ALERT WAS SENT OUT TO NURSING TO EXAMINE AND SECURE ALL OTHER PUMPS WITH THIS DEFECT. TO DATE, 6 OTHER PUMPS WITH OUTER HINGE CRACKS HAVE BEEN IDENTIFIED (7 ALTOGETHER). 5 OF THE PUMPS WITH DEFECTIVE CASING OF THE OUTER HINGE WERE MANUFACTURED IN 2006, 1 PUMP WAS FROM 2011 AND THE OTHER PUMP WAS FROM 2013."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661495 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention PRI TUBING,8015,