BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF MACRB EX ST (CAS/48)

    MDR report key: 3894367 · Received April 23, 2014

    Report

    Report Number
    9613251-2014-00091
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    K113683
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED LEAK OF THE FILTER ON THE TUBING SET WERE IDENTIFIED. 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 A LEAK. THE TUBING SET WAS BEING USED TO DELIVER UNSPECIFIED VOLUMES OF LIPIDS AND PROPOFOL. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT SOLUTION LEAKED FROM THE AIR VENTS OF THE AIR ELIMINATING FILTER OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL TO THE PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING, IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245875 LS LF MACRB EX ST (CAS/48) 80FPA FPA HOSPIRA, LTD NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK