BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT COMMANDER PPC

    MDR report key: 966629 · Received December 19, 2007

    Report

    Report Number
    1628664-2007-00596
    Event Type
    Injury
    Date Received
    December 19, 2007
    Date of Event
    November 21, 2007
    Report Date
    November 28, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    K897158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE COMPLAINT TEXT, THE LID CAME DOWN ON THE OPERATOR'S FINGER DUE TO THE OPERATOR NOT OPENING THE LID ENOUGH TO FULLY ENGAGE THE GAS SPRINGS USED BY THE SYSTEM TO HOLD UP THE LID. THE FSR VERIFIED THE GAS SPRINGS WERE WITHIN SPECIFICATIONS AND THEREFORE NO MALFUNCTION OF THE LID OCCURRED. THE ISSUE IS DUE TO USER ERROR. THIS ISSUE IS ADDRESSED IN THE COMMANDER PARALLEL PROCESSING CENTER (PPC) OPERATIONS MANUAL (69-0116/R2-NOVEMBER 1997): SECTION 7 OPERATIONAL PRECAUTIONS AND LIMITATIONS; SECTION 8 HAZARDS: PHYSICAL AND MECHANICAL SAFETY: BASIC RULES OF MECHANICAL OPERATION ARE ESSENTIAL TO SAFE OPERATION OF THE PPC. OPERATORS SHOULD PRACTICE SOUND MECHANICAL SAFETY HABITS THAT INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: KEEP ALL PROTECTIVE COVERS IN PLACE WHEN PROCESSING SPECIMENS, VERIFY THAT ALL COVERS ARE SECURELY OPEN TO PREVENT INADVERTENT CLOSURE, USE CARE WHEN CLOSING COVERS SO AS NOT TO PINCH HANDS OR FINGERS, DO NOT ALLOW ANY BODY PARTS TO ENTER THE RANGE OF MECHANICAL MOVEMENT DURING PPC OPERATION, DO NOT WEAR CLOTHING OR ACCESSORIES THAT COULD BE CAUGHT IN THE PPC, KEEP POCKETS FREE OF ANYTHING THAT COULD FALL INTO THE PPC, USE PROPER PRECAUTIONS AND LIFTING TECHNIQUES WHEN MOVING OR TRANSPORTING THE PPC, AND ALLOW ENOUGH TIME TO COMPLETE ALL PROCEDURES CORRECTLY. NOTE: BE ESPECIALLY CAUTIOUS WHEN PERFORMING SERVICE OR MAINTENANCE PROCEDURES. THE INVESTIGATION DEMONSTRATED THAT THE ABBOTT COMMANDER PARALLEL PROCESSING CENTER (PPC) IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) AT THE CUSTOMER SITE REPORTS THAT ONE OF THE OPERATORS OF THE COMMANDER PARALLEL PROCESSING CENTER (PPC) RECEIVED AN INJURY WHEN THE LID OF THE PPC CAME DOWN ON HER FINGER. THE OPERATOR WAS PERFORMING MAINTENANCE PROCEDURES ON THE NIGHT SHIFT AND DID NOT ENGAGE THE DEVICE'S LID THE ENTIRE LENGTH UP SO THAT THE GAS SPRINGS WERE NOT ENGAGED AND THE LID CAME DOWN ON HER FINGER. THE OPERATOR RECEIVED MEDICAL ATTENTION FOR A FRACTURED FINGER (VIA X-RAY) AND IS WEARING A SPLINT. MEDICATION FOR PAIN WAS ALSO PRESCRIBED. NO FURTHER MEDICAL TREATMENT WAS ADMINISTERED. THE FSR THEN WENT ABOUT AND INSPECTED ALL FOUR PPCS AT THIS SITE AND FOUND ALL FOUR TO BE IN PROPER WORKING CONDITION WITH NO ISSUES WITH ANY OF THE GAS SPRINGS AND ALL LIDS PERFORMING TO WITHIN ABBOTT SPECIFICATIONS. THERE IS NO FURTHER IMPACT TO THE OPERATOR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER PPC AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQW ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other