BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3030917 · Received March 28, 2013

    Report

    Report Number
    9615050-2013-00556
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 15, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICES WERE DISCARDED. 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 INFORMATION 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 CRACKS IN THE SEMI-RIGID ADAPTER OF THE SECONDARY PORT; SUBSEQUENTLY, LEAKS WERE NOTED. ON UNSPECIFIED DATES, THE PRIMARY TUBING SETS WERE PRIMED WITH NORMAL SALINE AND LOADED INTO PLUM PUMPS. AT UNSPECIFIED TIMES, THE MALE ADAPTER OF SECONDARY TUBING SETS WERE CONNECTED TO THE CLAVE SECONDARY PORT OF THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF UNSPECIFIED MEDICATIONS. IT WAS REPORTED THAT AFTER THE SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT, SOLUTION LEAKED ONTO THE FLOOR FROM A CRACK IN THE SEMI-RIGID FEMALE ADAPTER OF THE SECONDARY PORT. THE PRIMARY TUBING SETS WERE REPLACED AND THE THERAPIES WERE INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127663 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SECONDARY TUBING SETS, LIST # 14229, LOT # UNK