BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3113192 · Received May 8, 2013

    Report

    Report Number
    9615050-2013-01098
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 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 MEDICATION, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVERY OF UNSPECIFIED PREMEDICATIONS. THE CUSTOMER CONTACT REPORTED THAT AFTER THE PREMEDICATION WAS DELIVERED, THE MALE ADAPTER OF THE SECONDARY TUBING SET WAS THEN CONNECTED TO A NEEDLELESS VALVE CONNECTOR. IT WAS REPORTED THAT THE MALE ADAPTER OF A NEEDLELESS VALVE CONNECTOR CONNECTED TO THE CLAVE SECONDARY PORT FOR A PIGGYBACK DELIVERY OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME AFTER THE PIGGYBACK DELIVERY WAS STARTED, THE PUMP ALARMED FOR OCCLUSION. AT THIS TIME, THE NURSE DISCONNECTED THE NEEDLELESS VALVE CONNECTOR FROM THE CLAVE SECONDARY PORT AND SILICONE SLEEVE OF THE CLAVE SECONDARY PORT REMAINED IN THE DEPRESSED POSITION. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS. NO REPORTED DELAYS OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200374 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 251265H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED SECONDARY TUBING SET: LIST AND LOT/UNK| UNSPECIFIED SPIROS CONNECTOR: MFR: ICU MEDICAL INC