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 10/09/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on (b)(6) 2016.The fse found a leak from the tubing through pinch valve (pv37).The fse replaced the tubing through pv37 resolving the leak.The repairs were verified per established service procedures.The beckman coulter internal identifier for this event is (b)(4).

Event Description

The customer reported approximately 20 ml of clenz leaked from a coulter lh 500 hematology analyzer.The leak was not contained.The customer was wearing personal protective equipment (ppe) consisting of a laboratory coat 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 affect to patient treatment in connection to the event.There was no impact to patient results and 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: 6064700
• MDR Text Key: 58717316
• Report Number: 1061932-2016-00924
• 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: 10/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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: 10/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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