MAUDE Adverse Event Report: BECKMAN COULTER UNICEL® DXH 600 COULTER® CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number B23858

Device Problem Device Emits Odor (1425)

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

Event Date 01/09/2014

Event Type  malfunction  

Event Description

The customer reported a burning smell coming from the unicel dxh 600 coulter cellular analysis system.The customer did not observe any fire, smoke, sparks, arcs, or flames associated with the burning smell.The fire department was not called and a fire extinguisher was not used.The customer also reported discovering a leak which was contained inside the instrument.The customer was wearing personal protective equipment consisting of a laboratory coat, gloves, and eyewear at the time of the event and no injury or direct exposure with the leak was reported.No patient results were impacted and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

(b)(6).A field service engineer (fse) was dispatched to the customer's site.The fse evaluated the instrument and confirmed the leak coming from the quick disconnect at valve vl211.The fse replaced the quick disconnect at vl211 to resolve the issue.The fse determined that the fluid from the leak had wetted the electronic supply module causing the burning smell.The fse cleaned and dried the basic board to resolve the issue.Results: failure mode of the event is attributed to the quick disconnect at pinch valve vl21; fluid leaked from the quick disconnect onto the electronic supply module causing the burning smell.(b)(4).

• Brand Name: UNICEL® DXH 600 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 boulevard; brea, CA 92821 ; 7149614941
• MDR Report Key: 3602692
• MDR Text Key: 4066684
• Report Number: 1061932-2014-00234
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B23858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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