BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3022991 · Received March 21, 2013

    Report

    Report Number
    9615050-2013-00453
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 22, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICES WERE DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LEAKS. ON UNSPECIFIED DATES, THE OPTION-LOK MALE ADAPTER OF THE TUBING SETS WERE CONNECTED TO THE PATIENT'S I.V. ACCESS SITES AND WERE BEING USED TO DELIVER EITHER UNSPECIFIED MEDICATIONS OR UNSPECIFIED CHEMOTHERAPEUTIC AGENTS, AT UNSPECIFIED RATES, VIA PLUM PUMPS. AFTER UNSPECIFIED LENGTHS OF TIME, THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED VOLUMES OF SOLUTIONS LEAKED FROM UNSPECIFIED LOCATIONS AT THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SETS ONTO THE PATIENTS AND ONTO THE FLOOR. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTION WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE LEAK OF SOLUTIONS WERE CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117368 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 230065H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK