MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number 629029

Device Problems Circuit Failure (1089); Fluid/Blood Leak (1250); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2014

Event Type  malfunction  

Event Description

The affiliate stated the customer reported diluent leaked within the instrument, came in to contact and short circuited the solenoid expansion board involving the unicel dxh 800 coulter cellular analysis system.The customer then observed a small amount of smoke emitted from the instrument with a burning odor.There was no fire, sparks, arcs, or flames.The fire department was not requested, and the fire extinguisher was not used.The operator was wearing proper personal protective equipment (ppe) consisting of gloves, a laboratory coat, and eye protection and did not have direct contact with the fluid.There was no operator injury or adverse effect associated with this event.The customer indicated patient results were not impacted.There was no patient consequence associated with this event.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

The field service engineer (fse) observed a few milliliters of diluent leaked from the loose quick disconnect (qd211).The fse tightened qd211 and resolved the fluid leak issue.The fse replaced the solenoid expansion board and cables to resolve the burnt solenoid expansion board issue.The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.In conclusion, the likely cause of the event is attributed to the loose quick disconnect, qd211.A definitive root cause is unknown.(b)(4).

• Brand Name: UNICEL DXH 800 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 FL 33196
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 4000236
• MDR Text Key: 20972408
• Report Number: 1061932-2014-01917
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K120771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 629029
• Other Device ID Number: SOFTWARE VERSION 2.0.2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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