BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM LFS PRIM PMP

    MDR report key: 3905836 · Received May 29, 2014

    Report

    Report Number
    9615050-2014-03699
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 7, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. TESTING FOUND THAT SOLUTION LEAKED FROM THE PROXIMAL AIR VENT OF THE AIR ELIMINATING FILTER. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS LEAKS THROUGH THE AIR VENTS. 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 NORMOSANG 250MG, AT A RATE OF 150ML/HR, VIA A PLUM PUMP. NO SPECIFIC DETAILS WERE PROVIDED. IT WAS REPORTED THAT 40 MINS AFTER THE DELIVERY WAS STARTED, APPROX 20-25 MLS OF SOLUTION LEAKED FROM THE PROXIMAL AIR VENT ON THE FILTER OF THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT THE THERAPY WAS STOPPED WITH APPROX ONE-FIFTH OF THE VOLUME OF THE SOLUTION LEFT WAS NOT INFUSED. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317402 PLM LFS PRIM PMP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 330765H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR