MAUDE Adverse Event Report: BECKMAN COULTER COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605526

Device Problems Complete Blockage (1094); Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument on (b)(4) 2016.The fse found an obstruction at the probe rinse block.He removed the obstruction and the instrument ran without any leaks.The repairs were verified per established service procedures.(b)(4).

Event Description

The customer observed a fluid leak of 3 ml from a coulter hmx hematology analyzer with autoloader.The leak was not contained within the instrument and no error messages were reported by the customer at the time of the occurrence.The customer was wearing personal protective equipment consisting of a laboratory coat, goggles 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: COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
• 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: 5418013
• MDR Text Key: 37735813
• Report Number: 1061932-2016-00079
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010765
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• 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