BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3894201 · Received February 14, 2014

    Report

    Report Number
    9615050-2014-01208
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 17, 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
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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

    THE CUSTOMER CONTACT REPORTED DEVICE BREAKAGE; SUBSEQUENTLY, A LEAK WAS NOTED. ON AN UNSPECIFIED DATE, THE PRIMARY TUBING SET WAS CONNECTED TO THE PT'S CENTRAL VENOUS ACCESS CATHETER AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, A 10 ML SYRINGE WAS CONNECTED TO THE DISTAL CLAVE-Y SITE TO CHECK FOR BLOOD RETURN. AFTER BLOOD RETURN WAS CONFIRMED, THE DISTAL CLAVE Y-SITE AND TUBING WERE FLUSHED. AFTER THE TUBING WAS FLUSHED, A SECONDARY TUBING SET WAS CONNECTED TO THE DISTAL CLAVE Y-SITE FOR THE PIGGYBACK DELIVERY OF VINCRISTINE. NO SPECIFIC DETAILS WERE PROVIDED. IT WAS REPORTED THAT FIVE MINUTES AFTER THE DELIVERY WAS STARTED, THE PT'S PARENTS CALLED OUT TO THE NURSING STATION THAT THE TUBING SET WAS LEAKING. THE CUSTOMER CONTACT REPORTED THAT THE NURSE INDICATED THAT THE CENTER SILICONE BARRIER HAD POPPED OUT OF THE DISTAL CLAVE Y-SITE OF THE TUBING SET. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION APPEARED TO BE LEAKING AT THE BASE OF THE BLUE CASING WHERE IT CONNECTS TO THE TUBING OF THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT THE NURSE TURNED OFF THE PUMP, CLAMPED THE TUBING, AND DISCONTINUED THE THERAPY. THE CUSTOMER CONTACT INDICATED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED INTO THE BEDSHEETS AND A LITTLE ONTO CLOTHES. IT WAS REPORTED THAT THE LINENS AND THE SKIN SURFACES WERE WASHED. NO SPECIFIC DETAILS WERE PROVIDED. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. DURING VISUAL EXAMINATION AT THE USER FACILITY, IT WAS REPORTED THAT THE DISTAL CLAVE Y-SITE HAD COMPLETELY LOST THE SILICONE BARRIER LEAVING THE BLUNT CANNULA EXPOSED INSIDE OF THE OUTER CAUSING OF THE CLAVE Y-SITE. THE CUSTOMER CONTACT REPORTED THE PT RECEIVED LESS MEDICATION THAN INTENDED DUE TO NOT KNOWING HOW MUCH MEDICATION THE PT ACTUALLY RECEIVED; HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98625 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 340595H

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR UNSPECIFIED 10ML SYRINGE| SECONDARY TUBING SET: 20124, LOT #UNK