BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS

    MDR report key: 2854244 · Received October 24, 2012

    Report

    Report Number
    2854244
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 24, 2012
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    RECENTLY CHANGED OVER TO CAREFUSION MAXPLUS CAPS. STAFF STARTED REPORTING THE FOLLOWING ISSUES: BLOOD DRIPPED OUT OF ENTRY OF CAP OR SQUIRTED OUT OF END OF CAP SOILING GLOVES OR CLOTHING OF HEALTHCARE WORKER (6 REPORTS), IN 4 REPORTS STAFF REPORTED CAPS NOT CLEARING OF BLOOD WHEN FLUSHED WITH VOLUMES BETWEEN 5 AND 20CCS, 5 REPORTS INVOLVING BACKUP OF IV FLUIDS, LIPIDS AND/OR BLOOD, 2 REPORTS OF PARTIAL DISCONNECTS. THESE EVENTS OCCUR WITH ADMINISTRATION OF IV FLUIDS AND/OR MEDICATION WHEN CAP IS BACKING UP WITH IV FLUIDS AND/OR BLOODS, BLOOD SPRAY/SQUIRTING OCCURRING WITH BLOOD DRAWS.======================MANUFACTURER RESPONSE FOR MAXPLUS CLEAR NEEDLELESS CONNECTORS, MAXPLUS CLEAR NEEDLELESS CONNECTORS (PER SITE REPORTER).======================INFUSION SAFETY APN VISITED FACILITY AND INTERVIEWED STAFF TO HEAR ISSUES. WORKING WITH CAREFUSION COMPANY. ON-SITE VISIT PLANNED FOR LATER THIS MONTH BY COMPANY MANUFACTURER. COMPANY REP MAY HAVE LOT NUMBERS WE DO NOT- ALL LOTS AT OUR FACILITY WERE PULLED. COMPANY CAME AND NOTED 50% LESS SILICONE USED IN MANUFACTURING PRODUCT- CORRECTED PER THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXPLUS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *