BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD LATEX FREE SYMBIQ PUMP SET

    MDR report key: 2581686 · Received May 16, 2012

    Report

    Report Number
    9615050-2012-00570
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    April 1, 2012
    Report Date
    April 17, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 114305H. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K041550. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT, VIA A SYMBIQ PUMP. IT WAS REPORTED THAT PRIOR TO CONNECTING THE TUBING SET TO THE PT'S IV ACCESS SITE, THE NURSE NOTED THAT THE TUBING HAD SEPARATED FROM THE LEG OF DISTAL Y-CLAVE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THERE WERE NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD LATEX FREE SYMBIQ PUMP SET UNK FRN HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA