BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET 2 CLAVES 272CM NDEHP

    MDR report key: 2741624 · Received August 31, 2012

    Report

    Report Number
    9615050-2012-01014
    Event Type
    Malfunction
    Date Received
    August 31, 2012
    Date of Event
    January 1, 2010
    Report Date
    June 29, 2012
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE ¿OTHER¿ FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF A 510K OF K865060. THIS REPORT REPRESENTS ALL THE INFO 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 DEVICE BREAKAGE; SUBSEQUENTLY, LEAKS OF CHEMOTHERAPEUTIC AGENTS WERE NOTED. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED CHEMOTHERAPEUTIC AGENTS, AT UNSPECIFIED RATES, VIA PLUM PUMPS. AFTER UNSPECIFIED LENGTHS OF TIME, IT WAS REPORTED THAT THE CLAVE SECONDARY PORT ON THE CASSETTES OF THE TUBING SETS BROKE OFF AND UNSPECIFIED VOLUMES OF CHEMOTHERAPEUTIC AGENTS LEAKED. THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED VOLUMES OF CHEMOTHERAPEUTIC AGENTS CAME IN CONTACT WITH UNSPECIFIED LOCATIONS ON THE NURSES. THE CUSTOMER CONTACT REPORTED THAT THE NURSES WERE WEARING PERSONAL PROTECTIVE EQUIPMENT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE NURSES. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD¿L INFO WAS PROVIDED, INCLUDING IF THE SOLUTIONS THAT LEAKED WERE CLEANED UP ACCORDING TO THE USER FACILITY¿S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUMSET 2 CLAVES 272CM NDEHP 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA 081615H

    Patients

    Seq Age Sex Outcome Treatment
    1