BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3905794 · Received May 29, 2014

    Report

    Report Number
    9615050-2014-03728
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 30, 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

    ONE USED DEVICE WAS REC'D AND EVALUATED. TESTING FOUND THAT SOLUTION LEAKED FROM THE DISTAL AIR VENT OF THE AIR ELIMINATING FILTER. THE PROBABLE CAUSE OF THE LEAK AT THE AIR VENT COULD HAVE BEEN RELATED TO THE COMBINATION OF LOW SURFACE TENSION OF THE SOLUTION INFUSED THROUGH THE AIR ELIMINATING FILTER AND PEAKS OF HIGH PRESSURE. A CONTRIBUTING FACTOR COULD BE DUE TO THE SOLVENT APPLICATION METHOD OF THE SEMI-RIGID ADAPTER TO THE FILTER PORT OF THE FILTER. 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 A LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT AN UNSPECIFIED LOCATION OF THE FILTER OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAY IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317436 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