BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF MIF MAC EXT (CAS/48)

    MDR report key: 2503758 · Received March 19, 2012

    Report

    Report Number
    9613251-2012-00043
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 21, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 AIR IN THE TUBING DISTAL TO THE FILTER. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TOTAL PARENTERAL NUTRITION, AT AN UNSPECIFIED RATE, VIA A GEMSTAR PUMP. THE SECURE LOCK MALE ADAPTER OF A GEMSTAR TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE EXTENSION SET. ON AN UNSPECIFIED DATE, IT WAS REPORTED THAT THE HOMECARE PATIENT PRIMED THE TUBING SET WITH THE AIR ELIMINATING FILTER OF THE EXTENSION SET "LYING ON THE FLOOR." IT WAS REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME AFTER THE DELIVERY WAS STARTED, AN UNSPECIFIED VOLUME OF AIR WAS NOTED IN THE TUBING DISTAL TO THE AIR ELIMINATING FILTER. NO AIR WAS DELIVERED TO THE PATIENT. THE HOMECARE PATIENT NOTIFIED THE USER FACILITY AND WAS INSTRUCTED TO EITHER REPLACE THE EXTENSION SET OR DISCONNECT THE EXTENSION SET FROM THE IV ACCESS SITE AND REPRIME TO REMOVE THE AIR. THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF MIF MAC EXT (CAS/48) 80FPK FPK HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT #062055H| GEMSTAR PRIMARY TUBING SET: LIST #13758