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	10/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) evaluated the instrument on 03-oct-2016.The fse found that the stabilyse tubing had disconnected from the diff mix chamber (vc25) causing the reagent to be dispensed onto the diff chamber module.The fse replaced the stabilyse input tubing to the side port of the vc25 and secured the tubing onto the port resolving the issue.The fse replaced a noisy diff mix motor assembly as a preventative measure.The repairs were verified per established service procedures.(b)(4).
Event or Problem Description
The customer reported an unspecified volume of stabilyse leaked from the coulter lh 750 hematology analyzer.The customer was wearing personal protective equipment (ppe) consisting of a laboratory coat, gloves and glasses 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 affect to patient treatment in connection to the event.There was no impact to patient results and controls.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 6053505
• Report Number: 1061932-2016-00919
• Device Sequence Number: 1838337
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/03/2016

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: 10/03/2016
• 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