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

Catalog Number 629029

Device Problems Fluid/Blood Leak (1250); Device Emits Odor (1425); Device Inoperable (1663); Device Displays Incorrect Message (2591); Electronic Property Issue (2928)

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

Event Date 08/25/2014

Event Type  malfunction  

Event Description

While on site, a beckman coulter (bec) field service engineer (fse) reported a leak from the customer's unicel dxh 800 coulter cellular analysis system.The volume of the leak was approximately 2 ml and came from a quick disconnect inside the vcsn module.The leak shorted out a cable connector and an electrical circuit board.The fse observed a burning smell, but did not observe any fire, sparks, or arcing.The fire department was not called and the laboratory was not evacuated.The instrument generated "solenoid is shorted" errors and became inoperable.The instrument operator was wearing a lab coat and gloves at the time of the leak.There were no reports of biohazard exposure to the leak.There were no erroneous results generated and patient treatment was not impacted in connection with this event.

Manufacturer Narrative

The fse corrected the leak by tightening the quick disconnect connector.Operation of the instrument was verified by replacing the damaged parts -- the vcsn temperature control board and ribbon cable and the pneumatic sensor.(b)(6).(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: 4101898
• MDR Text Key: 4720021
• Report Number: 1061932-2014-02326
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• 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 3.0.0.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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