BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1343961 · Received January 14, 2009

    Report

    Report Number
    2016493-2009-00006
    Event Type
    Malfunction
    Date Received
    January 14, 2009
    Report Date
    March 31, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER INITIAL REPORT WAS OF RECEIVING A DEVICE WITH A NOTE STATING NOT INFUSING PROPERLY. THE INITIAL REPORT OF NOT INFUSING PROPERLY MAY HAVE OCCURRED IN 2008. NO CLINICAL INFORMATION AVAILABLE AND EXACT DATE REPORTED AS UNKNOWN. NEW INFORMATION RECEIVED ON 01/13/2009 THAT THE DEVICE WAS USED IN 2008 AND WAS INVOLVED IN A PT. EVENT IN ICU. THIS EVENT WAS REPORTED AS A LEVOPHED INFUSION THAT WAS STARTED AT 05:30 AND FINISHED IN 1 1/2 HOURS INSTEAD OF 4 HOURS. RISK MANAGER CALLED FOR CLINICAL DETAILS; STATED NO REPORTS FOR THE INITIAL OCCURRENCE DATE AND PROVIDED INFORMATION FOR THE SECOND DATE IN QUESTION. REPORTED AN IV BAG INFUSED TOO FAST BUT THERE WAS NO PATIENT HARM. THE DEVICE WAS TESTED FOR RATE ACCURACY AS RECEIVED. THE DEVICE'S PERFORMANCE WAS SIGNIFICANTLY OUTSIDE THE SPECIFICATIONS AND PERIODS OF UNREGULATED FLOW WERE OBSERVED DURING TESTING. THE DEVICE FAILED THE UPPER OCCLUDER PRESSURE TEST. THE DEVICE WAS DISASSEMBLED AND INSPECTED. THE DEVICE WAS IDENTIFIED WITH A BROKEN UPPER HINGE POST ON THE PLATEN ASSEMBLY. THE CAUSE FOR THE UNREGULATED FLOW IS DUE TO A BROKEN UPPER HINGE POST ON THE PLATEN ASSEMBLY. THE RESULT OF THE TESTING SHOWED THAT A HARD FOREIGN OBJECT LODGED UNDER THE UPPER HINGE AREA OF THE PLATEN WITHIN THE BEZEL CAVITY IS CAPABLE OF APPLYING ENOUGH TORQUE TO BREAK THE UPPER HINGE POST WHEN THE DOOR IS CLOSED. THE PLATEN RETURNED FOR INSPECTION FOUND A STRESS MARK INDENTATION ON THE PLATEN ASSEMBLY. THE ROOT CAUSE FOR THE BROKEN UPPER HINGE POST OF THE PLATEN WITHIN THE LVP WAS THE RESULT OF SOME ABUSIVE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK