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
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) found that the waste tubing from an unrelated instrument in the laboratory became disconnected from the waste drain and caused a leak.The leak was sufficient to reach the connection point which was on the lab floor at which the dxh 900 was connected to an extension cord.It was confirmed that the only component that was burnt was the cable connection between the dxh 900 instrument spm (specimen transport module) and the extension cord going to the ups.To resolve the issue the fse removed the extension cord, replaced the damaged cables, rerouted them and elevated the ups to resolve the issue.The fse ran controls that passed to verify the repairs.Per the bec safety compliance engineer the following are the safety standards for the instruments/devices involved in this event: the dxh 900 meets the ivd laboratory equipment international safety standards iec 61010-1 and iec 61010-2-101.However, it¿s important to clarify that the dxh900 itself did not contribute to this event in any way.The powervar ups is certified to iec 62040-1(ed.1) and iec 62040-1(ed.1);am1, part 1: safety requirements for uninterruptible power systems (ups).Dxh900 ifu pn c06947ac section 1-55, table 1.6 states the following: ¿the 3 m (10 ft) primary power cord on the rear of the spm (specimen processing module) must be plugged directly into the receptacle.Do not use an extension cord.¿ bec internal identifier: case (b)(4).
Event or Problem Description
The customer reported there was a leak at the waste drain which caused the power plug of the dxh900 hematology instrument to spark and generate smoke.The dxh900 instrument generated the spark and smoke when an extension cord connected to the instrument came in contact with a leak.A fire extinguisher was used by the operators as a preventive measure and the fire department was called as required by laboratory protocol.There was no report of a visible flame.It was confirmed that the only component that was burnt was the cable connection between the instrument spm (specimen transport module) and the extension cord going to the ups.There was no other damage to the laboratory as a result of this event.There as one operator that complained of a sore throat but did not require any medical intervention or need time off from work.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: 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 FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16251114
• Report Number: 1061932-2023-00081
• Device Sequence Number: 5682478
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)190429
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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 DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown