MAUDE Adverse Event Report: BECKMAN COULTER FC 500; EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC

Catalog Number 6605628

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 10/31/2014

Event Type  malfunction  

Event Description

The customer reported system pressure and vacuum chamber errors and approximately 100 milliliters of fluid dripped between samples tubes onto the carousel while analyzing patient samples involving the fc 500 analyzer.The fluid was contained on the carousel.The operator was wearing proper personal protective equipment (ppe) consisting of gloves, a laboratory coat, and eye protection and did not have direct contact with the fluid.Patient results were not impacted.There was no patient consequence associated with this event.The customer performed system troubleshooting and flushed the vacuum chamber line and emptied the vacuum trap.The customer then performed a cleaning panel and resolved the reported issues.The instrument was returned to normal operation.

Manufacturer Narrative

Service was not dispatched as the customer resolved the issue through system diagnostics.(b)(4).

• Brand Name: FC 500
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC
• 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: 4256613
• MDR Text Key: 4992960
• Report Number: 1061932-2014-02852
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605628
• Other Device ID Number: SOFTWARE VERSION 2.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2004
• 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