BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA XPN 100 CENTRIFUGE

    MDR report key: 3171365 · Received June 14, 2013

    Report

    Report Number
    3007448124-2013-00002
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JQC
    PMA / PMN Number
    CLASS I EXEM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER INSTRUCTIONS PROVIDED WITH THE INSTRUMENT, DE-CRATING SHOULD BE PERFORMED AT GROUND LEVEL. THE CUSTOMER AT THE UNIVERSITY OF (B)(6) REQUIRED THE DELIVERY PERSONNEL TO DE-CRATE THE INSTRUMENT EVEN THOUGH LABELS ON THE CRATE INDICATED NOT TO ATTEMPT UNPACKING OR INSTALLATION OF THE INSTRUMENT. THE CAUSE OF THIS EVENT IS USER ERROR; THE EHL DELIVERY PERSONNEL AND THE CUSTOMER DID NOT ADHERE TO THE LABELS ON THE CRATE WHICH STATED NOT TO UNPACK THE INSTRUMENT. THE DAMAGED INSTRUMENT WAS LEFT AT THE UNIVERSITY OF (B)(6) FOR INSPECTION BY A BECKMAN COULTER FIELD SERVICE ENGINEER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INJURY WITH AN EHL (ELECTRONIC HANDLING LTD) DELIVERY PERSONNEL, AT THE UNIVERSITY OF (B)(6) DELIVERING THE OPTIMA XPN 100 CENTRIFUGE. THE CUSTOMER INDICATED THAT THE INSTRUMENT WAS ACCIDENTALLY DROPPED ON ONE OF THE DELIVERY PERSONNEL AND THE INDIVIDUAL SUFFERED A BROKEN TOE AS A RESULT OF THE EVENT. THE DELIVERY PERSONNEL WENT FOR AN X-RAY TO DIAGNOSE THE EXTENT OF THE INJURY. THE TWO DELIVERY PERSONNEL INVOLVED IN THE EVENT PROVIDED STATEMENTS OF THE INCIDENT AND STATED THAT THE EVENT OCCURRED AS THE INSTRUMENT ARRIVED ON TWO PALLETS FROM THE WAREHOUSE AND THE DELIVERY PERSONNEL TRIED TO REMOVE ONE OF THE EXTRA PALLETS. THE DELIVERY PERSONNEL UNBOLTED THE INSTRUMENT FROM THE PALLET AND LOADED THE INSTRUMENT ONTO A TAIL LIFT. WHILE ONE OF THE DELIVERY PERSONNEL MOVED THE PALLET OUT OF THE WAY, THE OTHER DELIVERY PERSONNEL STEADIED THE INSTRUMENT ON THE TAIL LIFT; THE DELIVERY PERSONNEL LOST HIS GRIP AND THE INSTRUMENT SLID SIDEWAYS OFF THE TAIL LIFT AND ONTO THE FOOT OF THE OTHER DELIVERY PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271138 OPTIMA XPN 100 CENTRIFUGE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE JQC BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other