BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 2152843 · Received June 23, 2011

    Report

    Report Number
    2016493-2011-00388
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 18, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOG REVIEW. THE OCCURRENCE OF CHANNEL DISCONNECTS IN THE DEVICE LOG WAS IDENTIFIED THROUGH DEVICE LOG REVIEW SUBSEQUENT TO A CUSTOMER SITE VISIT, WHICH WAS PERFORMED ON (B)(4) 2011, TO EVALUATE THE CUSTOMER'S REPORT OF COMMUNICATION ERRORS AND CHANNEL DISCONNECTS. THE CUSTOMER DID NOT REPORT ANY PT INVOLVEMENT WITH THIS DEVICE. THE CHANNEL DISCONNECT ISSUE COULD NOT BE DUPLICATED ON THE DEVICE DURING INVESTIGATION AT THE CUSTOMER SITE. ALTHOUGH OTHER DEVICES INSPECTED AT THE CUSTOMER'S SITE HAD INDICATIONS OF IUI CONTACT RELATED ISSUES AND EXHIBITED THE PRESENCE OF CONTAMINATION, WE COULD NOT DEFINITIVELY DETERMINE THE CAUSE OF THE LOGGED CHANNEL DISCONNECTS FOR THIS DEVICE. THE ROOT CAUSE FOR THE CHANNEL DISCONNECTS IS UNK.

    Description of Event or Problem · 1

    TWO CHANNEL DISCONNECT ENTRIES WERE DISCOVERED IN A REVIEW OF THE DEVICE EVENT LOG. THE LOG SHOWED THAT THE MODULE WAS NOT ACTIVELY INFUSING AT THE TIME OF THE DISCONNECTS, HOWEVER IT IS UNCERTAIN AS TO WHETHER OR NOT THE DEVICE WAS CONNECTED TO A PT AT THE TIME OF THE CHANNEL DISCONNECT EVENTS. THERE WAS NO REPORT OF PT HARM AND NO PT OR EVENT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

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