BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3113115 · Received May 9, 2013

    Report

    Report Number
    9615050-2013-01131
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN 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 CRACK IN THE SEMI-RIGID ADAPTER OF THE CLAVE SECONDARY PORT; SUBSEQUENTLY, A LEAK WAS NOTED. AT AN UNSPECIFIED TIME, THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE MALE ADAPTER OF AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT FOR THE PIGGYBACK DELIVERY OF AN UNSPECIFIED VOLUME OF NORMAL SALINE. THE CUSTOMER CONTACT REPORTED THAT 30 MINUTES AFTER THE DELIVERY WAS STARTED, THE NURSE REPORTEDLY OPENED THE PUMP DOOR TO BACK PRIME MEDICATION. NO SPECIFIC DETAILS WERE PROVIDED. AT THIS TIME, IT WAS REPORTED THAT THE NURSE FOUND THE CLAVE SECONDARY PORT "HOLDING BY A THREAD." THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. 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. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202778 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 230105H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK