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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

On 10/05/2016 the field service engineer (fse) found disconnected sweep flow tubing which caused the leak.The leak damaged various components which were causing the background failures.The fse replaced the tubing to fix the leak.The components that were damaged by the leak were replaced and the instrument ran without any further issues or errors.The repairs were verified per established procedures.(b)(4).

Event Description

The customer reported an uncontained cleaner leak of about 30 ml from the coulter hmx analyzer during startup.There were background failures reported by the customer at the time of the event.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.There was no impact to patient results and controls.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.

• Brand Name: COULTER HMX ANALYZER
• 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: 6045674
• MDR Text Key: 58028424
• Report Number: 1061932-2016-00874
• 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: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6605526
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1