MAUDE Adverse Event Report: BECKMAN COULTER COULTER® LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 178833

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Temperature Problem (3022)

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

Event Date 04/03/2014

Event Type  malfunction  

Event Description

The customer reported approximately 10 milliliters of blue fluid leaked from the lh500 instrument.The fluid leaked onto the counter during startup.The customer also stated the instrument generated ambient and lyse temperature errors.There was no biohazard exposure to open wounds or mucous membranes.No erroneous patient results were generated in connection with this event.

Manufacturer Narrative

A field service engineer (fse) was not dispatched.The customer technical specialist (cts) assisted the customer with replacing cut tubing through pv43 resolving the leak.The leak wet the connections to the peltier module.The cts recommended customer to power off instrument and dry the peltier connections.This resolved the errors when the customer powered on instrument.((b)(4).Customer resolved the issue.

• Brand Name: COULTER® LH 500 HEMATOLOGY ANALYZER
• 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: 3782549
• MDR Text Key: 4430242
• Report Number: 1061932-2014-00959
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042724
• 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: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2009
• 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