FDA Adverse Event Injury Summary report: N

XN HEMATOLOGY ANALYZER SORTER

MDR report key: 21034720 · Received December 30, 2024

Report

Report Number
MW5164000
Event Type
Injury
Date Received
December 30, 2024
Date of Event
October 4, 2024
Report Date
December 23, 2024
Manufacturer
SYSMEX AMERICA, INC.
Product Code
GKZ
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

AROUND 6:30 A.M. XN HEMATOLOGY ANALYZER SHORTER WAS NOT FUNCTIONING PROPERLY, (B)(6) WERE TRYING TO FIX THE ISSUE, AND I (B)(6) TRIED TO HELP THEM. AND WE WERE NOT SUCCESSFUL. WE CALLED THE SERVICE FOR FURTHER ASSISTANCE; WE WERE FOLLOWING THE INSTRUCTION FROM THE SERVICE GUY ((B)(6) FROM SYSMEX REF# (B)(4) ON THE PHONE TO SPRAY THE CANE AIR TO REMOVE THE DUST FROM THE CONVEYOR. AROUND 7:30 AM THE TECH. (B)(6) PERFORMING THIS ACTION, THERE WAS AN EXPLOSION WITH A BALL OF FIRE THAT ENSUED. HIS FRONT LAB COAT WAS MELTED, AND HIS FACE CAUGHT IN THE FLAME AND HIS GLASSES WERE BURNED, HIS EYEBROWS WERE SEARED, AND HE WENT TO ER. LAB CALL FOR CODE RED, THE FACILITY CAME AND TURN OFF POWER THE ENTIRE SYSTEM TO THE INSTRUMENT. CODE RED TEAM ARRIVE PROMPTLY. PER PATIENT'S EMR(ELECTRONIC MEDICAL RECORD): 60 Y.O. MALE WHO PRESENTS TO THE EMERGENCY DEPARTMENT AFTER BURN. WAS WORKING IN THE LAB IN THIS HOSPITAL WHEN A SMALL FIRE OCCURRED AND HAD ABOUT 1 SECOND OF FLAMES REACHING CLOSE TO HIS FACE. HE DOESN'T THINK THEY ACTUALLY MADE CONTACT WITH HIS FACE; WAS WEARING GLASSES. HE CURRENTLY C/O(COEXISTING) A BURNING SENSATION TO THE SKIN OF HIS FACE AND SLIGHT BURNING SENSATION IN BOTH EYES. NO FOREIGN BODY SENSATION, NO EYE TEARING, VISION IS INTACT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1732693 XN HEMATOLOGY ANALYZER SORTER COUNTER, DIFFERENTIAL CELL GKZ SYSMEX AMERICA, INC. BT-40

Patients

Seq Age Sex Outcome Treatment
1 60 YR Male Hospitalization