BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2943843 · Received January 30, 2013

    Report

    Report Number
    2016493-2013-00086
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES WERE RETURNED FOR THIS INVESTIGATION. THE CUSTOMER'S REQUEST FOR A LOG REVIEW FOR AN OVERINFUSION OF IV TYLENOL HAS BEEN COMPLETED. A REVIEW OF THE ASSOCIATED PCU EVENT LOG FOR THE TIME PERIOD IN QUESTION INDICATES THAT THE INITIAL ACETAMINOPHEN (TYLENOL) WAS PROGRAMMED AS A SECONDARY AT 4:42 PM TO INFUSE 23 MLS IN 15 MINUTES AT A RATE OF 92 ML/HR. THIS SECONDARY INFUSION COMPLETED IN 15 MINUTES AT WHICH TIME THE PRIMARY PARAMETERS RESUMED. AT 7:40 PM ANOTHER ACETAMINOPHEN SECONDARY WAS PROGRAMMED USING THE SAME PARAMETERS AS THE FIRST. THIS SECONDARY INFUSION ALSO COMPLETED IN 15 MINUTES AT WHICH TIME THE PRIMARY PARAMETERS RESUMED. ACCORDING TO THE LOG FROM THE TIME THE INITIAL SECONDARY INFUSION WAS PROGRAMMED (4:42 PM) UNTIL THE USER OBSERVED THE EMPTY SECONDARY CONTAINER (10:20 PM) A TOTAL OF 230 MLS OF FLUID WAS INFUSED (46 VIA SECONDARY PARAMETERS + 184 VIA PRIMARY PARAMETERS). IT SHOULD BE NOTED THAT IF THE USER DID NOT RETURN TO CLAMP OFF THE ACETAMINOPHEN CONTAINER WHEN THE SECONDARY COMPLETED, THE REMAINING VOLUME IN THE SECONDARY CONTAINER WOULD HAVE CONTINUED TO INFUSE AT THE PRIMARY RATE. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE COULD NOT BE DEFINITIVELY DETERMINED FROM A LOG REVIEW ALONE BUT INFORMATION AVAILABLE SUGGESTS IT IS LIKELY TO BE DUE TO USER ISSUE WHEN HANGING A SECONDARY CONTAINER WITH A VOLUME GREATER THAN INTENDED DOSE. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TYLENOL 230MG WAS SET-UP AS A SECONDARY INFUSION. THE PHARMACY SENT UP A CONTAINER OF 1000MG (100MLS) WHICH WAS HUNG. THE INTENDED VOLUME TO BE INFUSED WAS 23MLS. THE ENTIRE CONTAINER OF TYLENOL INFUSED BETWEEN 8-10PM. THE PATIENT REQUIRED LABS DRAWN TO CHECK LIVER FUNCTION AND POISON CONTROL WAS CALLED. THE PATIENT CONTINUED TO BE MONITORED. THE CUSTOMER REQUESTED A LOG REVIEW TO CHECK THE PROGRAMMING. CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40907 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS SYRINGE MODULE: SN (B)(4)| ALARIS PUMP MODULE ADMIN SET: MODEL UNK, LOT UNK| ALARIS PC UNIT: SN (B)(4)