BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP PRIMARY PLUM CLAVE Y

    MDR report key: 2329201 · Received October 24, 2011

    Report

    Report Number
    9615050-2011-00836
    Event Type
    Malfunction
    Date Received
    October 24, 2011
    Date of Event
    August 12, 2011
    Report Date
    September 26, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. (B)(4). THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K865060. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. 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 SET. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, AN UNSPECIFIED VOLUME OF AIR WAS NOTED IN THE TUBING SET DISTAL TO THE CASSETTE. IT WAS REPORTED THAT A HOLE WAS NOTED IN THE TUBING, "JUST BELOW THE CASSETTE." THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. 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 ADD'L INFO WAS PROVIDED INCLUDING IF ANY AIR WAS DELIVERED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP PRIMARY PLUM CLAVE Y 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM PUMP, LIST # UNK, SN UNK