BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3093472 · Received April 26, 2013

    Report

    Report Number
    9615050-2013-00955
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 AN UNSPECIFIED DATE, THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF HEPARIN, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSE REPORTED THE PUMP WAS ALARMING FOR AN UNSPECIFIED ALARM AND FOUND THAT THE SOLUTION CONTAINER WAS EMPTY. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED ONTO THE PUMP AND THE FLOOR. THE SOLUTION CONTAINER AND THE TUBING SET WERE 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 REQUIRED. DURING VISUAL EXAMINATION AT THE USER FACILITY, A HOLE IN THE TUBING PROXIMAL TO THE CASSETTE OF THE TUBING SET WAS NOTED. THOUGH REQUESTED, NO ADD¿L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181737 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1