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

Catalog Number B23858

Device Problems Leak/Splash (1354); Device Emits Odor (1425); Device Displays Incorrect Message (2591)

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

Event Date 05/25/2014

Event Type  malfunction  

Event Description

The customer reported a burning smell emitted from the instrument while running patient samples using the unicel dxh 600 coulter cellular analysis system.There were also several instrument generated error messages: "mrc board disabled" and "incorrect board detected" at the time of the event.The customer discontinued use of the instrument.A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the instrument.The fse identified a leak in the instrument as the cause of the burning smell reported by the customer.There were no flames, smoke, arcing or sparks associated with the event.There were no reports of biohazard exposure to open wounds or mucous membranes.The operator was wearing appropriate personal protective equipment of glasses, gloves and lab coat when the event occurred.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 determined the cause was a loose connection at quick disconnect, qd284 on wire marker 8 (line #8) from valve vl211 which allowed approximately 5ml of cleaner reagent to drip down from qd284 onto the vcsn temperature control board and the pneumatic sense board causing a short circuit at vl355.The field service engineer cleaned the instrument to remove dried cleaner residue and tightened the connection at qd284 at line 8 (wiremarker 8).The vcsn temperature control and the pneumatic sense boards were removed, cleaned of residual dried cleaner salts and dried before being re-installed.The vcsn temperature control and the pneumatic sense boards were replaced with new boards the following day.(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 blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 3875386
• MDR Text Key: 4564559
• Report Number: 1061932-2014-01315
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120771
• 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: 05/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• 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: 05/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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