BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3970786 · Received April 29, 2014

    Report

    Report Number
    9615050-2014-03087
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS 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

    THE CUSTOMER CONTACT REPORTED A CRACK IN THE SEMI-RIGID ADAPTER; SUBSEQUENTLY, A LEAK WAS NOTED. THE PRIMARY PLUMSET WAS PRIMED WITH AN UNSPECIFIED VOLUME OF NORMAL SALINE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE MALE ADAPTER OF A SECONDARY TUBING SET CONNECTED TO A NEEDLELESS CONNECTOR WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE PLUMSET FOR THE DELIVERY OF 250ML OF AN UNSPECIFIED CONCENTRATION OF ERBITUX, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER THE DELIVERY WAS JUST STARTED, IT WAS REPORTED THAT 10-30ML OF SOLUTION LEAKED FROM A CRACK IN THE SEMI-RIGID ADAPTER OF THE CLAVE SECONDARY PORT. IT WAS REPORTED THAT THE CLAVE SECONDARY PORT BROKE OFF. THE CUSTOMER CONTACT DESCRIBED THE SEMI-RIGID ADAPTER AS HARD AND BRITTLE. IT WAS REPORTED THAT SOLUTION LEAKED ONTO THE PUMP, ONTO THE CASSETTE OF THE TUBING SET, AND ONTO THE NURSE'S GLOVE. IT WAS REPORTED THAT THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY PROTOCOL. THE TUBING SET AND THE SOLUTION CONTAINER OF CHEMOTHERAPY WERE REPLACED AND THE THERAPY WAS RESUMED. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT INDICATED THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES FOR THE PHARMACY TO REMIX THE CHEMOTHERAPY; HOWEVER, NO MEDICAL INTERVENTIONS WERE REQUIRED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT OR TO THE NURSE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256383 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 360135H

    Patients

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