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 Contamination with Body Fluid (2317)

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

Event Date 05/28/2014

Event Type  malfunction  

Event Description

The customer reported blood on top of the sample tubes, and a possible leak, when using the unicel dxh 800 coulter cellular analysis system.A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the instrument.The fse identified a leak of approximately 0.5ml from the instrument.The leak was not contained within the instrument.The operator was wearing personal protective equipment.There were no reports of biohazard 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 identified a leak caused by insufficient vacuum supplied to the probe wipe.Solenoid 341, (vl341) was replaced to resolve the issue.(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: 3885967
• MDR Text Key: 4545843
• Report Number: 1061932-2014-01407
• 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: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• 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: 2.0.2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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