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	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) evaluated the lh750 on 09/ 22/ 2016 and found the needle bellows was not draining fully causing a leak, and replaced tubing at pinch valve vl57a resolving the reported leak.While onsite, the fse also observed the backwash cup (rinse trough) in the probe wipe module was broken and the whole module was replaced.The instrument ran without any further issues and was verified and validated.(b)(4).
Event or Problem Description
The customer reported approximately 50ml of bloody fluid leaked under their coulter lh750 hematology analyzer, no alarms were generated and the leak was not contained within the instrument; service was dispatched.The customer was wearing personal protective equipment (ppe) consisting of gloves, lab coat, and eye protection when the leak was identified and there was no biohazard exposure to mucous membranes or open wounds.There was no death, injury, or change to patient treatment and no erroneous results were generated in connection with the reported event.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer boulevard; brea CA 92821 6232
• MDR Report Key: 6028727
• Report Number: 1061932-2016-00842
• Device Sequence Number: 19006582
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/23/2016

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
• Device Age: 12 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1