BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE

    MDR report key: 4407076 · Received January 6, 2015

    Report

    Report Number
    2016493-2014-00590
    Event Type
    Malfunction
    Date Received
    January 6, 2015
    Date of Event
    August 29, 2014
    Report Date
    September 5, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUSPECT DEVICE NOT RECEIVED, PC UNIT & LOG REVIEW ONLY. THE REQUESTED LOG REVIEW WAS COMPLETED. THE PC UNIT WAS RETURNED; HOWEVER, THE SUSPECT PUMP MODULE WAS NOT RETURNED FOR INVESTIGATION. THE CUSTOMER PROVIDED NO INFORMATION ABOUT ANY INFUSIONS. THE LOG ANALYSIS NOTED THAT THE PUMP MODULE SN (B)(4) WAS RESPONSIBLE FOR THE INFUSION OF THE DRUG MIDAZOLAM_DRIP, AND HAD ITS DOSING INCREASED. THE INFUSION HAD A DOSING ENTRY OF 0.16MG/KG/H ENTERED ON (B)(6) 2014 AT 06:33AM. THE DOSING WAS INCREASED TO 1.6MG/KG/H AT 07:54AM. FOUR MINUTES LATER THE DOSE WAS DECREASED TO 1.22MG/KG/H. SIX MINUTES LATER THE USER ACCESSED THE DEVICE AND DECREASED THE DOSE TO 0.12MG/KG/H. THE TOTAL CALCULATED VOLUME INFUSED FOR THE TIME PERIOD THE DOSING IS BELIEVED TO HAVE BEEN INCREASED IN ERROR WAS 0.9959ML. EVERY INCREASE IN DOSAGE OVER THE LIMIT OF 0.5MG/KG/H RESULTED IN A SOFT GUARDRAILS ALERT WHICH WAS OVERRIDDEN BY THE USER. THE LOG REVIEW DID NOT FIND ANY OTHER ANOMALIES WITH THE OTHER MODULES PROGRAMMING OR INFUSION PERFORMANCES. IT IS NOT BELIEVED THAT A DEVICE MALFUNCTION OCCURRED. THE ROOT CAUSE FOR THE CUSTOMER'S REQUEST OF A LOG REVIEW FOR A PATIENT INCIDENT IS NOT DEFINITELY KNOWN BUT IS SUSPECTED TO BE ASSOCIATED WITH PROGRAMMING BY A USER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A PATIENT INCIDENT THAT OCCURRED BETWEEN 0445 TO 0840 ON (B)(6) 2014 AND WOULD LIKE AN EVENT LOG REVIEW. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. MANUFACTURER'S REPORT NUMBER: 2016493-2014-00590. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9730 ALARIS SYRINGE MODULE PUMP, INFUSION FRN CAREFUSION CORP 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 ALARIS SYRINGE MODULE TUBING, MODEL/LOT UNK| ALARIS PUMP MODULE, SNS (B)(4)| ALARIS SYRINGE MODULE, SN (B)(4)| ALARIS PC UNIT, SN (B)(4),| BD 30 ML SYRINGE, MODEL/LOT UNK,| ALARIS PUMP MODULE TUBINGS, MODEL/LOT UNK