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

Catalog Number 6605526

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

The customer was able to troubleshoot the leak with the help from customer technical service (cts) over the phone.No onsite service was provided.The customer found that the tubing had been disconnected from the front blood detector, bd1.Cts assisted the customer with reconnecting the tubing to the front blood detector resolving the leak.The repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported a diluent leak of approximately 5 ml from a coulter hmx hematology analyzer with autoloader during startup/shutdown.The leak was not contained within the instrument and blood detector error messages were reported at the time of the event.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat, face shield and gloves at the time of the event, 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 in connection to the event.

• Brand Name: COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
• 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-l23; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 6057343
• MDR Text Key: 58409033
• Report Number: 1061932-2016-00907
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590330576
• UDI-Public: (01)15099590330576(11)NO-DATA
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• 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: 09/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2010
• 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