BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3231088 · Received July 12, 2013

    Report

    Report Number
    9615050-2013-02023
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 17, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE SILICONE SLEEVE OF THE CLAVE SECONDARY PORT REMAINED IN THE DEPRESSED POSITION. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT A MALE ADAPTER OF A NEEDLELESS VALVE CONNECTOR CONNECTED TO A SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVER OF ETOPOSIDE. AFTER AN UNSPECIFIED LENGTH OF TIME AFTER THE PIGGYBACK DELIVERY WAS STARTED, THE PUMP ALARMED FOR PROXIMAL OCCLUSION. THE SECONDARY TUBING SET AND THE NEEDLELESS VALVE CONNECTOR WERE REPLACED AND THE THERAPY WAS RESUMED. IT WAS REPORTED THAT 25 MINUTES AFTER THE DELIVERY WAS STARTED, THE PUMP AGAIN ALARMED FOR PROXIMAL OCCLUSION. AT THIS TIME, THE NURSE DISCONNECTED THE NEEDLELESS VALVE CONNECTOR FROM THE CLAVE SECONDARY PORT AND THE SILICONE SLEEVE OF THE CLAVE SECONDARY PORT REMAINED IN THE DEPRESSED POSITION. THE PRIMARY TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322275 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 290835H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MFR BY ICU MEDICAL| SECONDARY TUBING SET: LIST # 14230, LOT # 240474W| SPIROS CONNECTOR: LIST # 20120, LOT # 220577HE,