BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1892862 · Received November 3, 2010

    Report

    Report Number
    2016493-2010-00481
    Event Type
    Other
    Date Received
    November 3, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 11/03/2010. (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. INSPECTION OF THE INTERNAL COMPONENTS OF THE DEVICE FOUND STICKY BROWN RESIDUE ON THE OCCLUDER FINGER POST AND UPPER PRESSURE SENSOR CONSISTENT WITH A FLUID INGRESS CONDITION. THIS RESULTED IN THE PUMPING FINGERS BECOMING STICKY. THE MECHANISM SUB ASSEMBLY AND UPPER PRESSURE SENSOR WERE REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS RETURNED TO THE FACILITY AFTER PASSING ALL REQUIRED SERVICE LEVEL TESTING. THE DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT SHOW ANY MANUFACTURING ISSUES DURING PRODUCTION BUILD FOR THE INVOLVED DEVICE. THE SERVICE DATABASE AND PRODUCT PERFORMANCE MONITORING DATABASE REVIEW SHOWED NO PRIOR ISSUES OR ANOMALIES HAVE BEEN REPORTED FOR THIS DEVICE.

    Description of Event or Problem · 1

    DURING ROUTINE SERVICE REPAIR, TECHNICIAN NOTED STICKY BROWN RESIDUE ON OCCLUDER FINGER POST AND UPPER PRESSURE SENSOR. BIOMED STATES NO HISTORY OF DEVICE BEING INVOLVED IN ANY RATE INACCURACY EVENTS OR PATIENT HARM. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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