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

Catalog Number 178833

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument on (b)(4) 2015.The fse found a leak at the bsv.He replaced the bsv pads and the instrument ran without any leaks.The repairs were verified per established service procedures.(b)(4).

Event Description

The customer observed a green fluid leak of 1 ml from the blood sampling valve, bsv, of a coulter lh 500 hematology analyzer.The leak was contained within the instrument and no error messages were reported by the customer at the time of the occurrence.The customer was wearing personal protective equipment consisting of a laboratory coat, goggles and gloves at the time of the event and 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.

• Brand Name: COULTER LH 500 HEMATOLOGY ANAYLZER
• 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; kendall FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue; 32-s08; kendall, FL 33196 ; 3053802031
• MDR Report Key: 5296756
• MDR Text Key: 34121318
• Report Number: 1061932-2015-01766
• 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,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• 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: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• 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