BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEHP FREE LS LF PLUMSET-OL CP D CHAN

    MDR report key: 4152548 · Received October 6, 2014

    Report

    Report Number
    9615050-2014-05486
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 18, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SEALED DEVICE WAS FROM LOT #39022 WAS RECEIVED ON (B)(4)2014 AND EVALUATED. VISUAL INSPECTION REVEALED NOTHING UNUSUAL WITH THE DEVICE. THE DEVICE PASSED TESTING. NO LEAK WAS NOTED DURING THE TESTING PROCEDURES. BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. 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 LEAK. THE PLUMSET WAS BEING USED TO DELIVER TRASTUZUMAB 21MG/DL- 441 MG/250ML AT A RATE OF 600ML/HR, VIA A PLUM PUMP. NO SPECIFIC DETAILS WERE PROVIED. AT 1300, TWENTY MINUTES AFTER THE DELIVERY WAS STARTED, THE CUSTOMER CONTACT REPORTED THAT A LITTLE SOLUTION LEAKED AT THE CONNECTION OF THE TUBING AND AN UNSPECIFIED CLAVE CONNECTOR OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO DELAY IN THERAPY CRITICAL TO THE PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622296 DEHP FREE LS LF PLUMSET-OL CP D CHAN 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR