BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN SAPPHIRE SYSTEM

    MDR report key: 15276522 · Received August 23, 2022

    Report

    Report Number
    2919069-2022-00023
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    July 31, 2022
    Report Date
    October 21, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740016616
    PMA / PMN Number
    K051215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SEE MFR REPORT REF# 2919069-2022-00024-00 FOR THE SMOKE EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B5-DESCRIBE EVENT OR PROBLEM: UPDATED WITH ADDITIONAL INFORMATION FROM THE CUSTOMER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.THIS FOLLOW UP INCLUDES A CORRECTION TO INCLUDE THE CODES IN SECTION H6 FOR COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS THAT WERE NOT INCLUDED IN THE INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE CELL-DYN SAPPHIRE¿S VACUUM ACCUMULATOR LEVEL SENSOR FAILED, ALLOWING FLUID TO FLOW INTO THE VACUUM AND OUT INTO THE TABLE AND FLOOR, CAUSING THE ABBOTTLINK POWER CORD TO GET WET. THE CUSTOMER STATED WHILE THE LAB ASSISTANT WAS CLEANING UP THE FLUID, THE LAB ASSISTANT FELT A SMALL SHOCK. THE CUSTOMER STATED NO MEDICAL TREATMENT WAS NEEDED AND THE LAB ASSISTANT WAS ABLE TO COMPLETE HER SHIFT. THE LAB ASSISTANT WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. HOWEVER, THE ANALYZER HAD NOT BEEN POWERED OFF WHEN THE FLUID WAS BEING CLEANED UP. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND REPLACED THE VACUUM ACCUMULATOR. THE FSE ALSO REPLACED THE POWER CORD FOR THE ABBOTTLINK FIREWALL. THERE WAS NO DAMAGE TO THE FACILITY REPORTED. THE INVESTIGATION INCLUDED REVIEW OF PRODUCT HISTORICAL DATA, PRODUCT LABELING AND CFT (CROSS FUNCTIONAL TEAM) MEETING. REVIEW OF PRODUCT HISTORICAL DATA FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE DID NOT IDENTIFY ANY ADVERSE TRENDS OR ABNORMAL COMPLAINT ACTIVITY. SECTION 8 OF THE CELL-DYN SAPPHIRE OPERATOR¿S MANUAL PROVIDES INFORMATION ON POTENTIAL HAZARDS TO PERSONNEL AND POTENTIAL DAMAGE TO THE LABORATORY ENVIRONMENT. THE CFT (CROSS FUNCTIONAL TEAM) MEETING DETERMINED THAT USE ERROR CONTRIBUTED TO THE ISSUE AS THE OPERATIONS MANUAL STATES, ¿KEEP LIQUIDS AWAY FROM ALL ELECTRICAL OR COMMUNICATION COMPONENT CONNECTORS. DO NOT TOUCH WITH WET HANDS ANY SWITCHES OR OUTLETS.¿ BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CELL-DYN SAPPHIRE FOR SERIAL NUMBER 43060AZ WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE VACUUM ACCUMULATOR OF THE CELL-DYN SAPPHIRE ANALYZER HAD OVERFLOWED AND LEAKED OUT TO THE TABLE AND FLOOR. WHILE CLEANING UP THE FLUID, THE LAB ASSISTANT CUSTOMER FELT A SMALL SHOCK. THE CUSTOMER STATED NO MEDICAL TREATMENT WAS NEEDED AND SHE COMPLETED HER SHIFT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND FOUND DRIED VACUUM PUMP WHICH CAUSED THE VACUUM ACCUMULATOR TO OVERFLOW. NO MEDICAL TREATMENT NEEDED FROM THE ELECTRIC SHOCK.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 29AUG2022. THE ANALYZER HAD NOT BEEN POWERED OFF WHEN THE FLUID WAS BEING CLEANED-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831628 CELL-DYN SAPPHIRE SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 08H00-01 00380740016616

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability