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 04/12/2014

Event Type  malfunction  

Event Description

The customer reported that the unicel dxh 800 coulter cellular analysis system generated blood detector errors.Additionally, the customer also reported an electrical burning smell coming from the instrument.The customer did not see any smoke, arcs, or flames for this event.The fire department was not called and the fire extinguisher was not used.The customer immediately powered down the analyzer and unplugged the analyzer from the power source.There was no injury associated with this event.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

A field service engineer (fse) was dispatched to the customer's site.The fse evaluated the instrument and confirmed that the tubing through pinch valve vl462, above the blood sampling valve (bsv) blood detector, was disconnected and fluid had leaked onto the blood detector causing an electrical smell.The fse proceeded to replace the blood detector and reconnected the tubing through vl462 to resolve the issues.In conclusion, failure mode of the leak is attributed to a disconnected tubing through vl462.Fluid then leaked from the disconnected tubing onto the blood detector causing the electrical smell.The unicel dxh 800 coulter cellular analysis system conforms to the following safety standards: (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 boulevard; brea, CA 92821 ; 7149614941
• MDR Report Key: 3801291
• MDR Text Key: 4368164
• Report Number: 1061932-2014-01029
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081930
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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