MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number 629029

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 11/25/2015.The fse found that the probe wash collar was broken.The fse replaced the probe wash collar, which repaired the leak.The repairs were verified by the fse.(b)(4).

Event Description

The customer reported a bloody leak from the unicel dxh 800 cellular analysis system.The volume of he leak was about 4 cc and was not contained within the instrument.The customer was wearing personal protective equipment (ppe) consisting of gloves, goggles and a laboratory coat at the time of the occurrence and there was no report of injury or direct exposure to the leak.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

• Brand Name: UNICEL DXH 800 CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami, FL 33196 ; 3053802031
• MDR Report Key: 5316517
• MDR Text Key: 34078386
• Report Number: 1061932-2015-01864
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1