BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2507016 · Received March 14, 2012

    Report

    Report Number
    2016493-2012-00148
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 28, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT RETURN EXPECTED, THE CUSTOMER DECLINED AN EVENT LOG REVIEW OR DEVICE EVAL BY CAREFUSION CUSTOMER ADVOCACY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVER INFUSION OF NITROGLYCERIN (NTG). REPORTED NTG WAS TO INFUSE AT 3 ML/HOUR BUT THAT IT INFUSED AT 33 ML/HR. REQUESTED AN EVENT LOG REVIEW TO DETERMINE HOW THE INFUSION WAS PROGRAMMED, RATE, IF GUARDRAILS EDITOR WAS USED, IF THE USER OBTAINED ANY ALERTS AND IF THE ALERTS WERE OVER RIDDEN. BIOMED STATED THEY REVIEWED THE EVENT LOGS, SPOKE WITH THE USER AND IDENTIFIED THE CAUSE OF THE OVER INFUSION AS USER PROGRAMMING. THE INTENDED PROGRAMMING WAS NTG 50 MG/250 ML, RATE=3 ML/HR (DOSE= 10 MCG/MIN). THE USER ENTERED THE DOSE=33 MCG/MIN (RATE= 9.9 ML/HR). THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET: MODEL/LOT# UNK| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)