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	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) evaluated the instrument and observed a crack in valve pv37 tubing.He replaced pv37 tubing which fixed the leak.The repairs were verified per established service procedures.(b)(4).
Event or Problem Description
The customer reported an uncontained leak from the coulter lh 500 hematology analyzer while performing shutdown.The volume of the leak was approximately 2ml.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.There was no impact to patient results and controls.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat, goggles and gloves at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.

• 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: 6073807
• Report Number: 1061932-2016-00941
• Device Sequence Number: 888495
• Product Code: GKZ
• UDI-Device Identifier: 15099590265045
• UDI-Public: (01)15099590265045
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/07/2016

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: 10/07/2016
• Initial Report FDA Received Date: 11/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1