BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA REFURB 802.11

    MDR report key: 3912636 · Received May 14, 2014

    Report

    Report Number
    9615050-2014-03418
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    March 29, 2014
    Report Date
    April 17, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 PATIENT RECEIVED LESS MEDICATION THAN INTENDED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A SIGNED NOTE THAT STATED, "PUMP DELIVERY AMOUNT DOES NOT MATCH EMPTYING OF SYRINGE. PUMP SET 8.4ML SHOULD BE MISSING BUT ONLY 6ML WAS ACTUALLY GONE." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, NO SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288260 LC PCA REFURB 802.11 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK