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

Catalog Number 6605526

Device Problems Leak/Splash (1354); Device Emits Odor (1425); Device Operates Differently Than Expected (2913)

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

Event Date 04/19/2015

Event Type  malfunction  

Event Description

Upon inspection of a reported burning smell the field service engineer (fse) found a leak inside the coulter hmx analyzer with autoloader.The customer had also reported the instrument was failing backgrounds when the burning smell was noticed.The volume of the leak was not specified and was contained within the instrument.There was no report of injury or direct exposure to the leak.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 4/20/2015.The fse found that the sweepflow tubing had become disconnected and was causing the leak.The fse reattached the tubing, which repaired the leak.The repairs were verified per established procedures.(b)(4).

• Brand Name: COULTER HMX ANALYZER WITH AUTOLOADER
• 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-l23; miami, FL 33196 ; 3053802031
• MDR Report Key: 4777172
• MDR Text Key: 5817839
• Report Number: 1061932-2015-00811
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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