MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Codes	Leak/Splash (1354); Blocked Connection (2888)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The field service engineer (fse) reported that when removing a clog from the dxh800 instrument with a syringe, bleach splashed into the eye of an operator who was observing.The operator was wearing only a laboratory coat for ppe and was not wearing face protection at the time of the incident.The fse removed the clog from the instrument and the laboratory supervisor reminded the operator to use eye protection when partaking in troubleshooting activity.The operator did not sustain any long term or significant damage as a result of the splash in the eye.Bec internal identifier - case-(b)(4).
Event or Problem Description
The field service engineer (fse) reported that while removing a clog from the dxh800 instrument with a syringe, bleach splashed into the eye of an operator who was observing.While troubleshooting the white blood cell (wbc) bath, the fse pushed bleach through the clogged lines with a syringe and tubing became loose and splashed bleach.An operator from the laboratory was observing and bleach splashed into their eyes.The operator then rinsed their eyes at the wash station and after that was taken to the emergency room.The operator was prescribed an eye ointment.The operator was out from work for two days but has since returned at full capacity and fully recovered from the incident.The operator was wearing only a laboratory coat for ppe and was not wearing face protection at the time of the incident.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer; brea CA 92821
• MDR Report Key: 12000503
• Report Number: 1061932-2021-00080
• Device Sequence Number: 19730154
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other