BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLPAKER COLLECTION DEVICE

    MDR report key: 2598908 · Received May 18, 2012

    Report

    Report Number
    2530131-2012-00006
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 25, 2012
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    LMF
    PMA / PMN Number
    P050044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED AND THEREFORE NO DEVICE EVALUATION COULD BE COMPLETED. IT WAS NOTED THAT THE NURSE TRANSFERRED PLASMA BY PUSHING ON THE CELLPARKER PLUNGER RATHER THAN BY PULLING ON THE PLUNGER OF THE EMPTY TRANSFER SYRINGE WHICH IS THE PERFORMED METHOD OF TRANSFER INDICATED IN THE INSTRUCTIONS FOR USE. IT WAS ALSO NOTED THAT THE NURSE WAS INEXPERIENCED IN THE USE OF THE DEVICE. AS CONTENTS ARE UNDER PRESSURE DURING TRANSFER, A SLIGHTLY ASKEW CONNECTION AND INCORRECTLY PUSHING ON THE PLUNGER OF THE CELLPAKER MAY LEAD TO LEAKAGE AND SPRAY UPON PLASMA TRANSFER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE DELIVERING THE DEVICE TO THE STERILE FIELD WAS SUBJECTED TO BLOOD EXPOSURE ABOUT HER FACE AND EYES WHEN AIRBORNE DROPS OF SPUN BLOOD PRODUCT EJECTED FROM THE INTERFACE BETWEEN THE CELLPAKER AND THE PLASMA CONTAINING TRANSFER SYRINGE. THE NURSE LEFT THE OPERATING ROOM IMMEDIATELY TO RINSE THE EXPOSURE SITE AND SEEK MEDICAL ATTENTION FOR AN EXPOSED INCIDENT. HAVING ALREADY THE PLASMA CONTAINING TRANSFER SYRINGE TO THE STERILE FIELD, THE PROCEDURE CONTINUED AS PLANNED. THE OUTCOME TO THE NURSE IS UNK, BUT NO FURTHER ADVERSE EVENTS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLPAKER COLLECTION DEVICE NONE LMF ORTHOVITA, INC. N1109001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK