BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3983144 · Received July 2, 2014

    Report

    Report Number
    9615050-2014-04274
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 9, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 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. AT AN UNSPECIFIED TIME, THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED BLOOD PRODUCT. AFTER AN UNSPECIFIED LENGTH OF TIME, DURING THE DELIVERY, IT WAS REPORTED THAT THE NURSE NOTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT THE CUSTOMER REPORTED HARD CONNECTION TO THE CASSETTE. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388191 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1