BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRM PB W/YLW KEY SC 3CLV BC AND OL

    MDR report key: 3905830 · Received May 29, 2014

    Report

    Report Number
    9615050-2014-03730
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 5, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICES WERE DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED LEAKS WERE IDENTIFIED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT REC'D OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LEAKS. ON UNSPECIFIED DATES, THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED VOLUMES OF NORMAL SALINE. AFTER UNSPECIFIED LENGTHS OF TIME, IT WAS REPORTED THAT UNSPECIFIED VOLUMES OF SOLUTION LEAKED AT UNSPECIFIED LOCATIONS OF THE FILTER OF THE TUBING SETS. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAYS IN THERAPY CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317401 PRM PB W/YLW KEY SC 3CLV BC AND OL 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK