BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONDEHP LS LF PLUMSET-OLCP D-CHAN

    MDR report key: 3874291 · Received April 18, 2014

    Report

    Report Number
    9615050-2014-02800
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED THREE POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS (PLOTS) ARE 340425H, 350075H, 330495H. 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 AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED TIME, THE MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE PLUMSET FOR THE PIGGYBACK DELIVERY OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER THE CHEMOTHERAPY DELIVERY WAS COMPLETE, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. NO SPECIFIC DETAILS WERE PROVIDED. THE LOCATION OF THE LEAK WAS DESCRIBED AS AT THE CONNECTION POINT OF THE TOP OF THE CLAVE SECONDARY PORT AND THE SECONDARY TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. IT WAS REPORTED THAT THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238773 NONDEHP LS LF PLUMSET-OLCP D-CHAN 80FPA FPA HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK POSSIBLE LOT #310324W| SECONDARY TUBING SET: LIST #14230,