BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2052472 · Received March 15, 2011

    Report

    Report Number
    2016493-2011-00228
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    September 21, 2010
    Report Date
    September 23, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 03/15/2011. (B)(4). CAREFUSION PERSONNEL WERE NOTIFIED OF THIS EVENT DURING A SITE VISIT. ENGINEERS FROM CAREFUSION DOWNLOADED THE LOGS AND PERFORMED A RUDIMENTARY EVALUATION OF THE DEVICES AT THE CUSTOMER SITE. A FULL FAILURE INVESTIGATION WAS NOT PERFORMED AND THE CUSTOMER DECLINED TO RETURN THE DEVICES TO CAREFUSION FOR FURTHER ANALYSIS. THE CUSTOMER'S COMPLAINT OF CHANNELS DISCONNECTING DURING TRANSPORT WAS VERIFIED. THE EVENT LOG WAS REVIEWED TO DETERMINE THE NUMBER OF DISCONNECTS. A TOTAL OF 23 SIMULTANEOUS MODULE REMOVALS AND RE-CONNECTIONS OCCURRED OVER 18 HOURS ON TWO PUMP MODULES, SN (B)(4) AND SN (B)(4). OF THE 23, 5 OCCURRED WHILE THE DEVICES WERE IDLE AND 18 DURING AN INFUSION RESULTING IN A "CHANNEL DISCONNECTED" ALARM. THIS ALARM PROVIDES AN AUDIO AND VISUAL ALERT TO NOTIFY THE USER TO TAKE APPROPRIATE ACTIONS. DURING THE DEVICE INSPECTION, IT WAS NOTED THAT MANY OF THE RIBS ON THE MALE IUI CONNECTOR ON SN (B)(4) WERE BROKEN AND DAMAGED. THE ROOT CAUSE OF THE CHANNEL DISCONNECT WAS NOT IDENTIFIED; HOWEVER, THE DAMAGED IUI CONNECTOR COULD BE RELATED TO THE REPORTED ISSUE. UPON FURTHER EVALUATION, WE HAVE DETERMINED THIS TO BE REPORTABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CHANNEL DISCONNECT. STATED THE ISSUE OCCURRED WHILE THE ANESTHESIOLOGIST WAS ASSISTING WITH THE PATIENT TRANSPORT. NO PATIENT HARM REPORTED OR MEDICATION INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT DETAILS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)