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

Catalog Number 178833

Device Problems Leak/Splash (1354); Positioning Problem (3009)

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

Event Date 05/13/2015

Event Type  malfunction  

Event Description

While troubleshooting a reported leak from the coulter lh 500 hematology analyzer the field service engineer (fse) found that the blood sampling valve (bsv) was not rotating properly.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 5/14/2015.The fse found that the blood sampling valve (bsv) was not rotating properly.The fse replaced the bsv actuator, which repaired the issue.The repairs were verified per established procedures.(b)(6).

• Brand Name: COULTER LH 500 HEMATOLOGY ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-l23; miami, FL 33196 ; 3053802031
• MDR Report Key: 4817972
• MDR Text Key: 5900331
• Report Number: 1061932-2015-00927
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• 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 VER 2A6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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