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

Catalog Number 178833

Device Problems Thermal Decomposition of Device (1071); Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/14/2014

Event Type  malfunction  

Event Description

The customer reported the coulter lh 500 hematology analyzer was generating 5c abnormal ii vote out all parameters.The customer stated that the instrument did not generate hemoglobin (hgb) result.The customer noticed a burning smell was coming from the instrument after it was placed into shutdown cycle.The customer powered off and unplugged the instrument from the electrical outlet.There was no actual smoke, only an electrical burn smell.There was no death, injury, or change to patient treatment attributed to or connected with this event.

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument.The fse observed disconnected tubing from the sweep flow check valve which caused a small amount of diluent to leak onto the peltier module (cause of burning smell), adjacent solenoid valves and the differential mixing motor.The leak was contained within the instrument.When the instrument was powered on, the instrument generated voltage errors/messages and was inoperable.The fse replaced the tubing and check valve for the sweep flow and replaced the peltier module, the solenoid valves and the differential mixing motor to resolve this issue.The fse verified the instrument and the instrument was returned to normal operation.(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: 3972098
• MDR Text Key: 4627788
• Report Number: 1061932-2014-01781
• 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: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• 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: SW VERSION: 2A6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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