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 Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

The customer reported an uncontained leak of approximately ten (10) milliliters from the coulter lh 500 hematology analyzer.The instrument generated "temperature" error messages when the leak was noticed.There was no direct contact with the leak.The customer was wearing personal protective equipment consisting of glasses, gloves, and laboratory coat.No erroneous results were generated in association with this event.A beckman coulter (bec) field service engineer (fse) was dispatched to the customer site.

Manufacturer Narrative

The fse found that the customer resolved the leak issue by replacing the tubing on pinch valve pv37, which had a hole.The fse found that the "temperature" error messages were caused by a peltier module that was damaged by the leak.The fse replaced the peltier module to resolve the "temperature" error messages.(b)(4).

• 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: 4052798
• MDR Text Key: 4901292
• Report Number: 1061932-2014-02165
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 178833
• Other Device ID Number: SOFTWARE VERSION 2A6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• 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