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

Catalog Number	6605632
Medical Device Problem Codes	Fluid/Blood Leak (1250); Split (2537)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) evaluated the instrument on 10/12/2016.The fse found a leak during the backwash portion of the aspiration cycle from the tubing connecting fitting (ft13-3) to diff segment valve (cvl85/126).The fse observed that the tubing was old and there was a small split in the tubing under the retention collar.The fse replaced ft13-3 and all the associated tubing resolving the leak and the differential voteouts on the controls.The repairs were verified per established service procedures.The beckman coulter internal identifier for this report is (b)(6).
Event or Problem Description
The customer reported a leak of unspecified volume on a coulter lh 750 hematology analyzer.The instrument had generated differential voteouts on controls at the time of the event.The leak was contained within the instrument and was a mixture of diluent and whole blood.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat 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 affect to patient treatment in connection to the event.There was no impact to patient results.

• 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: 6083420
• Report Number: 1061932-2016-00925
• Device Sequence Number: 16230203
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/12/2016

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: 10/12/2016
• Initial Report FDA Received Date: 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1