BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA III INFUSER

    MDR report key: 4142950 · Received September 12, 2014

    Report

    Report Number
    9615050-2014-05196
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    April 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K043256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE SHUTS OFF ON ITS OWN AND AN E630 (SCREW ROTATION ERROR) ERROR CODE WAS NOTED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A SIGNED NOTE THAT STATED, "SHUTS OFF WON'T TURN BACK ON". NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE SHUT OFF ON ITS OWN AND AN E630 (SCREW ROTATION ERROR) ERROR CODE WAS NOTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565389 LC PCA III INFUSER 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK