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

Catalog Number 629029

Device Problems Leak/Splash (1354); Device Emits Odor (1425); Operating System Becomes Nonfunctional (2996)

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

Event Date 04/09/2014

Event Type  malfunction  

Event Description

The customer reported the system manager was locked and the module resource controller board was not responding when using the unicel® dxh 800 coulter® cellular analysis system.A beckman coulter field service engineer (fse) went to the customer's facility to evaluate the instrument.The fse identified a contained leak, causing damage to the module resource controller board and also observed a burning smell.There was no arcing, sparks or smoke seen and no static shock.The operators were wearing personal protective equipment of gloves and lab coats when the leak was identified.There was no exposure to mucous membranes or cuts.There were no erroneous test results associated with this event.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

On (b)(4) 2014, the field service engineer (fse) evaluated the instrument and indicated that the module resource controller (mrc) board 31 was not coming up and saw several errors for mrc 31 along with mix pressure errors.He found disconnected the tubing from quick disconnect (qd284) had caused a leak onto the mrc board.The board was replaced and the tubing from qd284 was corrected.(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: 3788741
• MDR Text Key: 4383811
• Report Number: 1061932-2014-00993
• 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: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• 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: 2.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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