BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA III INFUSER

    MDR report key: 2102836 · Received April 12, 2011

    Report

    Report Number
    9615050-2011-00352
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 14, 2011
    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
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SVC REP PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE PUMP DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THIS WAS DUE TO THE COLLAR NUT WAS OUT OF ADJUSTMENT. THE CAUSE FOR THE COLLAR NUT TO BE OUT OF ADJUSTMENT COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE PUMP DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA