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

Device Problems Leak/Splash (1354); Blocked Connection (2888)

Patient Problem Eye Injury (1845)

Event Date 05/26/2021

Event Type  Injury  

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 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
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12000503
• MDR Text Key: 256278249
• Report Number: 1061932-2021-00080
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other