BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 2925387 · Received January 17, 2013

    Report

    Report Number
    9615050-2013-00090
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 20, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 AIR IN THE TUBING DISTAL TO THE DEVICE WITH NO DEVICE ALARM. AT AN UNSPECIFIED TIME, LINE A OF THE DEVICE WAS PROGRAMMED TO DELIVER NORMAL SALINE 1000ML, AT A RATE OF 999ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 1000ML, AND THE DELIVERY WAS STARTED. AT 1310, THE NURSE REPORTED THAT IN 36 INCHES OF THE TUBING SET DISTAL TO THE DEVICE, LARGE BUBBLES AND AIR SEGMENTS WERE NOTED WITH NO DEVICE ALARM. THE DEVICE WAS REMOVED FROM CLINICAL SVS. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. NO AIR WAS DELIVERED TO THE PT. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26570 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR PLUS A+ SOFTWARE MODULE, LIST #12097,| SN (B)(4)