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

Catalog Number 178833

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument and observed that there was a leak from the tubing through pinch vavle pv 27.The fse replaced the tubing to resolve the issue.The repairs were verified per established service procedures.Beckman coulter internal identifier for this report is (b)(4).

Event Description

The customer reported approximately 20 mls of uncontained clear fluid leaked from their coulter lh 500 hematology analyzer during startup.There were no error messages reported by the customer at the time of the event.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.There was no impact to patient results and controls.The customer was wearing personal protective equipment (ppe) consisting of 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.

• 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, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 6041993
• MDR Text Key: 57932167
• Report Number: 1061932-2016-00911
• Device Sequence Number: 1
• Product Code: GKZ
• 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: 09/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• 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: 09/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2003
• 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