BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3983129 · Received July 2, 2014

    Report

    Report Number
    9615050-2014-04278
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT OF AN UNDOCUMENTED NUMBER OF INCIDENTS OF AIR IN LINE. THE TUBING SETS WERE PRIMED WITH UNSPECIFIED VOLUMES OF NORMAL SALINE USING A PRESSURE CUFF OR VIA GRAVITY. NO SPECIFIC DETAILS WERE PROVIDED. AFTER UNSPECIFIED LENGTHS OF TIME, IT WAS REPORTED THAT THE TUBING SETS WERE CONNECTED TO UNSPECIFIED CATHETERS THAT FEED DIRECTLY INTO THE LEFT ATRIUM FOR THE DELIVERY OF HEPARIN 1000U/ML, AT A RATE OF 999ML/HR, VIA A PLUM PUMP. THE CUSTOMER CONTACT REPORTED THAT THE SOLUTION CONTAINERS WERE AT ROOM TEMPERATURE. AFTER UNSPECIFIED LENGTHS OF TIME, DURING THE PROCEDURES, IT WAS REPORTED THAT MICRO-BUBBLES WERE NOTED THROUGHOUT THE TUBING OF THE TUBING SETS. THE CUSTOMER CONTACT INDICATED THAT THE PROCEDURES WERE STOPPED TO REMOVE THE BUBBLES. AFTER A CUSTOMER REPORTED SHORT TIME, IT WAS REPORTED THAT THE DELIVERY RATES WERE DECREASED TO 100ML/HR; HOWEVER, IT WAS REPORTED THAT MICRO-BUBBLES CONTINUED TO FORM IN THE TUBING. THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED 0.22 MICRO FILTER WAS CONNECTED AT AN UNSPECIFIED LOCATION OF THE TUBING SET; HOWEVER, THE CUSTOMER CONTACT INDICATED THAT EVEN MORE MICRO-BUBBLES WERE NOTED DOWN LINE. THE LOCATIONS OF THE MICRO-BUBBLES WERE DESCRIBED AS FROM ABOVE TO THE PATIENT END. IT WAS REPORTED THAT NO MEASURABLE AMOUNTS OF AIR WERE DELIVERED TO ANY PATIENTS. THE CUSTOMER CONTACT REPORTED THAT THE PUMPS DID NOT ALARM FOR AIR IN LINE. THE CUSTOMER CONTACT REPORTED THAT THE RESULT WAS WORSE WHEN THE TUBING SETS WERE PRIMED VIA GRAVITY. NO SPECIFIC DETAILS WERE PROVIDED. IT WAS REPORTED THAT THE TUBING SETS WERE REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL TO ANY PATIENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387969 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. 370615H

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION TUBING SETS, LIST #19116, LOT #39199NS