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

Catalog Number	723585
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) evaluated the instrument on 10/07/2016 and found a leak from check valve (cv 8) letting clenz bubbles out of the white blood cell (wbc) bath.The fse replaced the check bath resolving the leak.The fse also replaced pinch valve (vl10) which was loose and broken but did not malfunction and the aperture o-rings as a preventative measure.The instrument ran without leaks and all repairs were verified per established service procedures.(b)(4).
Event or Problem Description
The customer reported a leak of blood-diluent and cbc lyse fluid of approximately < 1.0 ml in volume which was contained within the coulter lh 780 hematology analyzer.The customer was wearing personal protective equipment (ppe) consisting of a laboratory coat and gloves at the time of the event.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 to the event.

• Brand Name: COULTER LH 780 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 6061786
• Report Number: 1061932-2016-00921
• Device Sequence Number: 422242
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061616
• 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: 723585
• 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: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1