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

Catalog Number 629029

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument on 11/23/2015.The fse found disconnected differential, diff, air mix and temperature control, amtc, sample line from the mix chamber.He replaced the diff amtc sample line and the instrument ran without any leaks and error messages.The repairs were verified per established service procedures.Beckman coulter internal identifier for this report is (b)(4).

Event Description

While the field service engineer (fse) was troubleshooting the instrument for the partial clog errors reported by the customer , the fse observed a fluid leak from a unicel dxh 800 coulter cellular analysis system.The volume of the leak was not specified.The leak was contained within the instrument.The fse was wearing personal protective equipment consisting of a laboratory coat and gloves at the time of the event 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 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; kendall FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue; 32-s08; kendall, FL 33196 ; 3053802031
• MDR Report Key: 5296777
• MDR Text Key: 34074560
• Report Number: 1061932-2015-01775
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• 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: 11/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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