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

Catalog Number	178833
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was able to troubleshoot the instrument with the help from customer technical service (cts) over the phone on 09/27/2016.The customer found a leak from tubing through pinch valve (pv37).Cts assisted the customer with replacing the tubing through pv37 which resolved the leak.The repairs were verified according to the customers established protocols.(b)(6).
Event or Problem Description
The customer reported approximately 10 ml of clear fluid leak from a coulter lh 500 hematology analyzer.The leak was not contained.The customer was wearing personal protective equipment (ppe) consisting of a lab coat, face shield and gloves at the time of the event and 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 effect to patient treatment in connection with the event.There was no impact to patient results or controls.

• Brand Name: COULTER LH 500 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 6051380
• Report Number: 1061932-2016-00905
• Device Sequence Number: 957994
• Product Code: GKZ
• UDI-Device Identifier: 15099590265045
• UDI-Public: (01)15099590265045(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1