BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX XE-5000 ANALYZER

    MDR report key: 3763448 · Received April 9, 2014

    Report

    Report Number
    3009711478-2014-00008
    Event Type
    Injury
    Date Received
    April 9, 2014
    Report Date
    March 12, 2014
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSMEX REAGENTS HAVE A WHITE PLASTIC STRAP TIED AROUND THE BOX DESIGNED TO SECURE THE BOX FLAPS AND THE CONTENTS DURING SHIPPING. IT IS NOT MEANT TO PERFORM AS A HANDLE FOR TRANSPORT. THE CURRENT REAGENT BOX CONFIGURATION DOES NOT HAVE CUT-OUTS OR HANDLES. GOOD LABORATORY PRACTICES WOULD INDICATE USING SAFETY MEASURES RECOMMENDED BY THE OCCUPATIONAL SAFETY & HEALTH (OSHA) AND NIOSH (NATIONAL INSTITUTE OF OCCUPATIONAL HEALTH AND SAFETY) TO LIFT HEAVIER OBJECTS SUCH AS THE REAGENT CUBE. FOR EXAMPLE, LIFTING AIDS SUCH AS A DOLLY OR A CART FOR TRANSPORT OR LIFTING WITH ASSISTANCE OF ANOTHER EMPLOYEE WOULD AID THE USER IN TRANSPORTING THE REAGENT CUBE AND AVOIDING POTENTIAL INJURY. THE EMPLOYER IS RESPONSIBLE FOR ASSESSING RISK AND PROVIDING ADEQUATE TRAINING AND ENGINEERING CONTROLS FOR ALL REAGENTS AND OTHER MATERIALS USED IN A LABORATORY. SEVERAL ATTEMPTS WERE MADE BY THE TECHNICAL SERVICE QUALITY SOLUTIONS MANAGER (TSQSM) TO CONTACT THE HOSPITAL'S RISK MANAGEMENT AND HUMAN RESOURCES DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS. IT IS UNKNOWN IF THE OPERATOR SUFFERED PERMANENT INJURY DUE TO THIS INCIDENT. THIS INCIDENT WILL BE REPORTED AS THE OPERATOR ENDURED SERIOUS INJURY TO THE SHOULDER WHICH REQUIRED SURGERY TO CORRECT.

    Description of Event or Problem · 1

    THE USER OF CELLPACK 20L REAGENT, PK-30L, CONTACTED THE SYSMEX TECHNICAL SERVICE CENTER (TAC) ON (B)(6), 2014 REGARDING A USER SAFETY ISSUE WHEN HANDLING THE REAGENT CUBE. THE COMPLAINANT INDICATED THAT DURING THE PROCESS OF LIFTING THE REAGENT BY THE PLASTIC STRAP THE OPERATOR TORE THE ROTATOR CUFF IN HIS SHOULDER. THE USER REPORTED THE INCIDENT TO OCCUPATIONAL HEALTH. THE INJURY REQUIRED SURGERY TO CORRECT AND THE OPERATOR WAS ABSENT FROM WORK FOR A SIX WEEK RECOVERY. THE DATE OF OCCURRENCE OF THE INCIDENT IS UNKNOWN. CELLPACK REAGENT IS ASSOCIATED WITH THE XE-5000 ANALYZER. CELLPACK IS A CLASS 1 MEDICAL DEVICE, PRODUCT CODE GIF, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213063 SYSMEX XE-5000 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XE-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other