BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ ITALIAN

    MDR report key: 3172057 · Received June 10, 2013

    Report

    Report Number
    9615050-2013-01573
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 14, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. 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 THE PT REC'D LESS MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, LINE A OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PARENTERAL NUTRITION AND THE DELIVERY WAS STARTED. LINE B WAS PROGRAMMED IN THE CONCURRENT MODE TO DELIVER AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED LINE A DID NOT DELIVER THE UNSPECIFIED VOLUME OF MEDICATION IN THE CONTAINER AS EXPECTED. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT INDICATED THAT LINE B DELIVERED PROPERLY. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE WAS REMOVED FROM CLINICAL SVC. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED, INCLUDING IF THERAPY WAS CONTINUED USING A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261601 PLUM A+ ITALIAN 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PULM A+ SOFTWARE MODULE: LIST #12097, SN (B)(4)