BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3070151 · Received April 15, 2013

    Report

    Report Number
    9615050-2013-00726
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 18, 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
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. 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 THE SILICONE SLEEVE OF THE CLAVE SECONDARY PORT REMAINED IN THE DEPRESSED POSITION. ON AN UNSPECIFIED DATE, 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 A NEEDLELESS VALVE CONNECTOR CONNECTED TO 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 AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSE DISCONNECTED THE NEEDLELESS VALVE CONNECTOR FROM THE CLAVE SECONDARY PORT. AT THIS TIME, IT WAS REPORTED THAT THE SILICONE SLEEVE OF THE CLAVE SECONDARY PORT REMAINED IN THE DEPRESSED POSITION AND AN UNSPECIFIED VOLUME OF CHEMOTHERAPEUTIC AGENT LEAKED. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161562 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SPIROS CONNECTOR: LIST #20120, MFR ICU MEDICAL INC| LIST #UNK, LOT #UNK| UNSPECIFIED SECONDARY TUBING SET: