MAUDE Adverse Event Report: BECKMAN COULTER FC500 FLOW CYTOMETER WITH CXP SOFTWARE; COUNTER, DIFFERENTIAL CELL

Catalog Number 626553

Device Problem Device Emits Odor (1425)

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

Event Date 01/06/2014

Event Type  malfunction  

Event Description

The customer reported a burning smell from near the fc500 flow cytometer with (b)(4) software and proceeded to shut down the instrument.There was no fire, sparks, or smoke associated with the event and no injury was reported.There was no impact to patient results since the instrument was unable to be turned on and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

A beckman coulter field service engineer (fse) was dispatched to the customer's site.The fse evaluated the instrument and discovered a damaged cable inside the power supply harness within the power supply assembly.The damaged cable resulted in one of the connectors (j106/p106) to melt creating the burning smell.The fse performed a thorough check and no other electrical shorting was revealed.The fse replaced the power supply harness to resolve the issue and verified the repairs per established procedures.Results: failure mode of the event is attributed to a malfunctioning power supply harness.(b)(4).

• Brand Name: FC500 FLOW CYTOMETER WITH CXP SOFTWARE
• 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: 3607109
• MDR Text Key: 14878977
• Report Number: 1061932-2014-00238
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 626553
• Other Device ID Number: CXP SOFTWARE VERSION 2.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2005
• 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