MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 723585

Device Problem Complete Blockage (1094)

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

Event Date 05/16/2015

Event Type  malfunction  

Event Description

While a field service engineer (fse) was troubleshooting an unrelated event, the fse discovered a partial clog in the bottom of the diff mixing chamber on a coulter lh 780 hematology analyzer.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.

Manufacturer Narrative

The fse replaced the diff mixing chamber, resolving the issue.The repairs were verified per established service procedures.(b)(4).

• Brand Name: COULTER LH 780 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: miranda holland ; 11800 sw 147th avenue, 32-l23; miami, FL 33196-2031
• MDR Report Key: 4824172
• MDR Text Key: 5841155
• Report Number: 1061932-2015-00946
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061616
• 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: 05/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• 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