BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA PLS II

    MDR report key: 3955473 · Received June 12, 2014

    Report

    Report Number
    9615050-2014-03989
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 21, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    MEA
    PMA / PMN Number
    K912928
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE CUSTOMER CONTACT STATED THE DEVICE WILL BE REPAIRED AT THE USER FACILITY. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 THAT THE DEVICE SHUTS OFF ON ITS OWN WHILE OPERATING ON BATTERY POWER. THE DEVICE WAS RETURNED TO THE MAINTENANCE DEPARTMENT FOR A REPORT OF NEEDING REPAIR. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PT INFORMATION, 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, IT WAS NOTED THAT THE DEVICE SHUT OFF ON ITS OWN WHILE OPERATING ON BATTERY POWER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346780 PCA PLS II 80MEA MEA HOSPIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK