BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3853436 · Received April 4, 2014

    Report

    Report Number
    9615050-2014-02529
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 9, 2014
    Report Date
    March 10, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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

    THE CUSTOMER CONTACT REPORTED A LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF CARDIZEM AT AN UNSPECIFIED RATE, VIA PLUM PUMP. THE CUSTOMER CONTACT REPORTED THAT AFTER THE INFUSION WAS INITIATED, THE PUMP AUDIBLY ALARMED FOR AN UNSPECIFIED ALARM CONDITION. AT THAT TIME, IT WAS NOTED THAT SOLUTION WAS LEAKING FROM THE BASE OF THE PUMP. THE CUSTOMER CONTACT REPORTED THAT WHILE ATTEMPTING TO TROUBLESHOOT, IT WAS NOTED THAT SOLUTION LEAKED FROM THE DIAPHRAGM ON THE CASSETTE OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204831 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR PLUM PUMP, LIST #UNK, SN: UNK