BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3030881 · Received March 28, 2013

    Report

    Report Number
    9615050-2013-00552
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 8, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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. ON UNSPECIFIED DATE, THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT UNSPECIFIED RATE, VIA PLUM PUMP. AFTER SPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM UNSPECIFIED LOCATION ON THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND IF THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127509 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK