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U.S. Department of Health and Human Services

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

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BECKMAN COULTER UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL Back to Search Results
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.
 
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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 Key10973328
MDR Text Key220634700
Report Number1061932-2020-00176
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier15099590701574
UDI-Public(01)15099590701574(11)191014
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140911
Number of Events Reported1
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 NumberTN,DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
Device Catalogue NumberC11478
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2020
Initial Date FDA Received12/08/2020
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 Number1
Patient Outcome(s) Other;
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