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

Catalog Number 6706366

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

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

Event Date 04/25/2014

Event Type  malfunction  

Event Description

The customer reported a leak when using the coulter act diff analyzer.The rbc (red blood cell) bath was overflowing on the instrument during startup.The leak was not contained within the instrument.The operator was wearing personal protective equipment including gloves, goggles and lab coat.There were no reports of exposure to mucous membranes or cuts.There was no report of erroneous test results associated with this event.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the instrument and found the drain line plugged.He flushed out drain line.(b)(4).

• Brand Name: COULTER ACT 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: dung nguyen ; 250 s kraemer blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 3825502
• MDR Text Key: 14877997
• Report Number: 1061932-2014-01125
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• 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: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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