MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 178833

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

The customer was able to troubleshoot the instrument with the help from customer technical service (cts) over the phone on 09/27/2016.The customer found a leak from tubing through pinch valve (pv37).Cts assisted the customer with replacing the tubing through pv37 which resolved the leak.The repairs were verified according to the customers established protocols.(b)(6).

Event Description

The customer reported approximately 10 ml of clear fluid leak from a coulter lh 500 hematology analyzer.The leak was not contained.The customer was wearing personal protective equipment (ppe) consisting of a lab coat, face shield and gloves at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection with the event.There was no impact to patient results or controls.

• Brand Name: COULTER LH 500 HEMATOLOGY ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue; 32-l23; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 6051380
• MDR Text Key: 58197205
• Report Number: 1061932-2016-00905
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590265045
• UDI-Public: (01)15099590265045(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042724
• 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: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2014
• 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