MAUDE Adverse Event Report: 250 S. KRAEMER BLVD UNICEL DXH 690T COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH690T HEMATOLOGY SYSTEM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dxh690t instrument leaked due to the flowcell being plugged.The field service engineer (fse) observed that the sample line was damaged causing the leak.The fse replaced the flow cell sample line with associated sleeves to resolve the leak issue.The leak overflowed out of the instrument and into the power strip it was plugged into, located beneath the instrument.The power strip malfunction and generated a visible spark as a results of the fluid leaking onto it.Per ifu p/n c06947ac in page f-4 there is a warning that stated, ¿the instrument¿s power cord cannot be connected to the power strip.¿ this is further supported by an entry in the installation and qualification checklist for 690t, p/n c11346, wherein these three checklist items appear.The main ac outlet is a three-wire outlet supplying 100 to 240 vac, nominal; 8.0 to 2.8a; 48 to 62 hz; single-phase power.The power connection for the instrument is required to be independent and not connected into multiplug power strip.Bec internal identifier (b)(6).
Event or Problem Description
The customer reported that the power strip where the dxh690t hematology instrument was plugged overloaded and generated sparks.The fire department was called and the laboratory evacuated.There was no indication of erroneous results being reported outside the laboratory.No reported change or effect on patient treatment.There was neither death or serious injury associated with the event.

• Brand Name: UNICEL DXH 690T COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): 250 S. KRAEMER BLVD; brea CA 92821
• MDR Report Key: 12172832
• Report Number: 1061932-2021-00086
• Device Sequence Number: 16527244
• Product Code: GKZ
• UDI-Device Identifier: 15099590729110
• UDI-Public: (01)15099590729110(11)200420
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TN,DXH690T HEMATOLOGY SYSTEM
• Device Catalogue Number: 34520
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1