BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC 5000 DUAL CHAMBER

    MDR report key: 1512457 · Received October 15, 2009

    Report

    Report Number
    9615050-2009-00237
    Event Type
    Malfunction
    Date Received
    October 15, 2009
    Date of Event
    June 1, 2009
    Report Date
    September 15, 2009
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENTS, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 11943. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K052052. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICES WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DISCONNECTIONS. THE SECURE LOCK MALE ADAPTERS OF THE TUBING SETS WERE CONNECTED TO NEEDLE-FREE ADAPTERS AND WERE BEING USED TO DELIVER UNSPECIFIED VOLUMES OF UNSPECIFIED SOLUTIONS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, IT WAS REPORTED THE SECURE LOCK MALE ADAPTORS OF THE TUBING SETS DISCONNECTED FROM THE NEEDLE-FREE ADAPTORS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN CRITICAL THERAPIES. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC 5000 DUAL CHAMBER UNKNOWN FPA HOSPIRA COSTA RICA LTD. NA 761115H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT #H86422-1, MANUFACTURED BY CODAN| SWAN LOCK NEEDLE-FREE ADAPTOR: LIST #UNK,