MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6706366

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the analyzer on (b)(4) 2016, and confirmed a fluid leak from the probe caused by the probe wipe rinse block which was not evacuating fluid properly through the vacuum tubing.The fse found a blockage in the vacuum tubing and cleared the blockage, resolving the leak and restoring normal device operation.

Event Description

A customer reported an uncontained leak of about 1 ml of clear fluid from the probe of a coulter ac·t diff analyzer, in addition to an overflow from the white bath.The customer was wearing personal protective equipment (ppe) consisting of gloves, goggles and a laboratory coat at the time the leak was noticed, and there was no exposure to open wounds or mucous membranes.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

• Brand Name: COULTER AC·T DIFF ANALYZER
• 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; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 6089463
• MDR Text Key: 59575061
• Report Number: 1061932-2016-00904
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973634
• 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: 10/14/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 6706366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2004
• 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