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 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the analyzer on 10/24/2016, and confirmed that the wbc bath was not draining properly due to a clot in the drain line from the wbc bath, contributing to an overflow (a leak) of fluid from the bath.The bath overflow was resolved by cleaning and clearing the line; the analyzer was then confirmed as operational.(b)(6).

Event Description

A customer reported an uncontained leak of approximately 4 ml of fluid, from a coulter ac t diff analyzer, described as an overflow from the white blood cell (wbc) bath.The customer was wearing personal protective equipment (ppe) consisting of gloves and a laboratory coat at the time the fluid leak was observed, and there was no report of exposure to open wounds or mucous membranes.Erroneous patient results were not generated and there was no change or affect to patient treatment associated with this event.

Manufacturer Narrative

Device manufacturing date revised to reflect correct manufacturing date of the device.

• 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: 6108273
• MDR Text Key: 60087436
• Report Number: 1061932-2016-00933
• 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,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• 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
• Date Manufacturer Received: 11/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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