BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3802756 · Received February 21, 2014

    Report

    Report Number
    9615050-2014-01415
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    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

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. TESTING FOUND THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET WAS TORN OFF. WHITE DRAG MARKS WERE NOTED ON THE SECONDARY PORT OF THE CASSETTE INDICATING USE OF FORCE. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS THE ISSUE OF DEVICE BREAKAGE OF THE CLAVE SECONDARY PORT. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE DEVICE BREAKAGE WAS DUE TO THE DESIGN OF CLAVE PORT THAT IS DIRECTLY BONDED TO THE SECONDARY PORT OF THE CASSETTE. 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 DEVICE BREAKAGE. SUBSEQUENTLY, A LEAK WAS NOTED. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER 5% DEXTROSE IN WATER, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE MALE ADAPTER OF A NEEDLELESS CONNECTOR OF AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF 142.8 MG OF OXALIPLATIN. THE CUSTOMER CONTACT INDICATED THAT THE SECONDARY TUBING SET REMAINED CLAMPED IN THE CLOSED POSITION. AT THIS TIME, IT WAS REPORTED THAT THE NURSE INDICATED THAT THE CONNECTION WAS RESISTANT. THE CUSTOMER CONTACT REPORTED THAT THE NURSE USED MORE FORCE TO TIGHTEN THE CONNECTION OF THE MALE ADAPTER AND THE CLAVE SECONDARY PORT. AT THIS TIME, THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF 5% DEXTROSE IN WATER LEAKED FROM THE SEMI-RIGID ADAPTER ON THE CASSETTE OF THE CLAVE SECONDARY PORT OF THE TUBING SET. THE PRIMARY TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108931 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR MFR: UNK| UNSPECIFIED SECONDARY TUBING SET WITH SPIROS,