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

Catalog Number 6706366

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

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

Event Date 04/19/2014

Event Type  malfunction  

Event Description

The customer reported the white blood cell (wbc) bath of the "act dif" analyzer was overflowing; the leak was not contained; the wbc background was also failing.No erroneous patient results were generated in connection with the reported event.

Manufacturer Narrative

A field service engineer (fse) was dispatched.The fse confirmed the event and replaced pinch valves lv14 and lv15 resolving the wbc bath overflow and the wbc start up failures.The fse also indicated that the tubing was pinched and improperly routed during the service visit which caused waste to back fill into the clenz reagent container.The fse re-routed lv13 tubing and flushed the clenz line with warm water then with bleach to disinfect.(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: 3809398
• MDR Text Key: 20973782
• Report Number: 1061932-2014-01061
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2014
• 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: 04/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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