MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number TN,DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

The available information reasonably suggests the reported issue was a use error.The fse placed a paper towel underneath the aspiration probe while it was in motion piercing his finger.Bec internal identifier case: (b)(4).

Event Description

A beckman coulter field service engineer (fse) punctured his finger on the piercing probe of a customer's unicel dxh 900 coulter cellular analysis system while servicing it.The fse went to the customer lab site for a leaky dxh900 aspiration probe.While addressing the leak, the fse placed a paper towel underneath the aspiration probe while it was in motion.The fse stated he had done this procedure before and thought he had a few more seconds, the probe extended and pierced his left index finger.The fse went to the emergency room where blood was drawn to screen for (b)(6).Baseline testing was performed; the first blood results came back b)(6).The fse will be scheduling two follow up appointments at 6 weeks and 6 months for his second and third round of (b)(6) shots.The fse reported he is healthy and able to continue with work.

• Brand Name: UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami; florida FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 10973328
• MDR Text Key: 220634700
• Report Number: 1061932-2020-00176
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)191014
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2020

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
• Device Operator: Health Professional
• Device Model Number: TN,DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/08/2020
• 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