BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA REFURB 802.11

    MDR report key: 3113157 · Received May 8, 2013

    Report

    Report Number
    9615050-2013-01111
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 17, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH A NOTE THAT STATED, "FAILURE MESSAGE KEEPS COMING UP AFTER ABOUT 30 MINUTES STARTING INFUSION." NO SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202424 LC PCA REFURB 802.11 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK