BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3231055 · Received July 12, 2013

    Report

    Report Number
    9615050-2013-02030
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 1, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICES WERE DISCARDED. 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

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF CLAVE SECONDARY PORTS REMAINING IN THE DEPRESSED POSITION. ON UNSPECIFIED DATES, THE PRIMARY TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT UNSPECIFIED RATES, VIA PLUM PUMPS. AFTER UNSPECIFIED LENGTHS OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE MALE ADAPTER OF NEEDLELESS VALVE CONNECTORS CONNECTED TO UNSPECIFIED SECONDARY TUBING SETS WERE CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE PRIMARY TUBING SETS FOR PIGGYBACK DELIVERIES OF UNSPECIFIED CHEMOTHERAPEUTIC AGENTS. AFTER UNSPECIFIED LENGTHS OF TIME AFTER THE PIGGYBACK DELIVERIES WERE STARTED, IT WAS REPORTED THAT THE PUMPS ALARMED FOR AIR IN LINE. THE CUSTOMER CONTACT REPORTED THAT THE NURSES BACKPRIMED THE PUMPS TO CLEAR THE ALARMS. IT WAS REPORTED THAT THE AIR IN LINE ALARMS COULD NOT BE CLEARED, THE NURSES DISCONNECTED THE NEEDLELESS VALVE CONNECTORS FROM THE CLAVE SECONDARY PORTS AND THE SILICONE SLEEVES OF THE CLAVE SECONDARY PORTS REMAINED IN THE DEPRESSED POSITION. THE PRIMARY TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321935 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 261125H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED SECONDARY TUBING SETS: LIST #UNK,| SPIROS CONNECTORS: LIST #UNK, MFR ICU MEDICAL| LOT #UNK