BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODLE

    MDR report key: 3964858 · Received July 16, 2014

    Report

    Report Number
    2016493-2014-00326
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 17, 2014
    Manufacturer
    CAREFUSION CORPORTATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE ASSOCIATED CPU EVENT LOG INDICATED THAT THE PUMP MODULE HAD BEEN IN USE FOR AT LEAST 5 DAYS PRIOR TO THE REPORTED INCIDENT DATE OF (B)(6) 2014. ACCORDING TO THE LOG THE DEVICE WAS OPERATING AT A FLOW RATE OF 10/1ML/HR WITH THE USER ENTERING A VTBI OF 11.1MLS AFTER EACH INFUSION COMPLETE ALARM. THE LOG REVIEW DID NOTE THAT AT 6:45PM ON THE DAY IN QUESTION THE INFUSION WAS PAUSED FOR AT LEAST 5 MINUTES BEFORE BEING RESTARTED BY THE USER. THE LOG CONTAINED NO OTHER SIGNIFICANT EVENTS. IT CANNOT BE DETERMINED FROM THE LOG REVIEW WHEN THE BAG OF TPN WAS ORIGINALLY HUNG OR HOW MUCH VOLUME AS IN THE BURETTE PRIOR TO THE LAST INFUSION. VISUAL INSPECTION AND FUNCTIONAL TESTING FOUND THE PUMP MODULE AND ASSOCIATED DISPOSAL IV SET IN GOOD WORKING CONDITION AND DELIVERING FLUID WITHIN SPECIFICATIONS. THE REPORTED OVER INFUSION OF TPN COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REOPRTED AN OVERINFUSION OF TPN IN THE NICU. TWENTY-TWO MLS INFUSED OVER 1 HOUR AND 10 MINUTES WHEN THE INTENDED RATE WAS FOR 10.1ML/HR. THE NURSE FOUND THIS WHEN THE PUMP ALARMED AND THE BURETTE WAS EMPTY. THE PATIENT'S GLUCOSE WAS SLIGHTLY ELEVATED BUT RETURNEDTO NORMAL WITHOUT ANY INTERVENTION. NO ADDITIONAL LAB WORK WAS NEEDED FOR THE EVENT. DEVICES AND TUBING WILL BE SENT BACK FOR INVESTIGATION. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED. MANUFACTURER'S REPORT NUMBER: 2016493-2014-00326. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416064 ALARIS PUMP MODLE INFUSION PUMP FRN CAREFUSION CORPORTATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PC UNIT, SN (B)(4)| MFR MODEL/LOT UNKNOWN| ALARIS PUMP MODULE ADMIN SET, 10015012/LOT UNKNOWN| ALARIS SYRINGE MODULE, SN (B)(4),| ALARIS SYRINGE MODULE, SN (B)(4),| MFR/MODEL/LOT UNKNOWN| 500ML BAG OF PARENTERAL NUTRITIONAL LVP,| TRIFUSE EXTENSION SET, MFR/MODEL/LOT UNK| ALARIS SYRINGE MODEL, SN (B)(4)| 25ML SYRINGE, MFR/MODEL/LOT UNKNOWN| NON-CAREFUSION EXTENSION SETS,