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

Catalog Number 178833

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

The fse evaluated the instrument.The fse found a leak at the tubing through pinch valve pv49.The fse replaced the tubing through pinch valve pv49, which repaired the leak.The repairs were verified by the fse.(b)(6).

Event Description

The customer reported a leak from the coulter lh 500 hematology analyzer.The volume of the leak was about 3 ml and was contained within the instrument.The customer was wearing personal protective equipment (ppe) consisting of gloves, goggles and a laboratory coat.There was no report of injury or biohazard exposure to open wounds or mucous membranes.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

Customer technical support (cts) helped the customer troubleshoot the leak over the phone.The customer indicated that the tubing at pinch valve pv49 was causing the leak.The customer replaced the tubing, which repaired the leak.The field service engineer (fse) did not go on site and that the malfunction was repaired by the customer.

• 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-s08; miami, FL 33196 ; 3053802031
• MDR Report Key: 6105530
• MDR Text Key: 59980204
• Report Number: 1061932-2016-00967
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• 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: 10/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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