MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number	6605632
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) evaluated the instrument.The fse found that tubing at the blood sampling valve (bsv) was crimped.The fse cleared reset the tubing, which repaired the leak.The repairs were verified by the fse.(b)(6).
Event or Problem Description
The customer reported a leak from the coulter lh 750 hematology analyzer.The volume of the leak was about 5 ml and was not contained within the instrument.The customer was wearing personal protective equipment (ppe) consisting of gloves 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.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• MDR Report Key: 6054043
• Report Number: 1061932-2016-00922
• Device Sequence Number: 10984998
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K061574
• 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): 10/02/2016

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: 6605632
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2016
• Initial Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1