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

Catalog Number 629029

Device Problems Device Emits Odor (1425); Device Displays Incorrect Message (2591)

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

Event Date 04/30/2014

Event Type  malfunction  

Event Description

The customer reported a burning smell coming from the back of the unicel dxh 800 coulter cellular analysis system while running latron quality control (qc).The customer stated a "pneumatic supply module exceeded the operating limits" system error was also obtained.The customer powered off the instrument.There were no sparks, arcs or flames.The lab was not evacuated and the fire department was not called.No erroneous results were generated in association with the event.There was no death, injury, or affect to user or to patient treatment attributed to this event.

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument.The fse found a quick disconnect 8 on the flow cell harness under the sheath tank was not tight and was leaking slightly (line provides diluent for sample line cleaning and interconnects to the sample line) onto the pneumatic services, temp control card and shorted solenoids.The fse tightened the quick disconnect and also replaced pneumatic module resource card (mrc), pneumatic sensor card, volume conductivity scatter (vcsn) temperature controller card, module id board and associated cables to resolve the issue with the solenoids damaged by the leak.The fse verified the instrument with no further issues.The instrument was returned to normal operation.(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: 3840019
• MDR Text Key: 4661670
• Report Number: 1061932-2014-01132
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081930
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• 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: SW VERSION: 3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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