MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 500 HEMATOLOGY ANALYZER

Catalog Number 178833

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument on 12/04/2015.The fse found cleaner reagent leaking from pinch valve vl37 from tubing between feedthru fittings ff107 to ff124 and all tubing at this pinch valve was replaced resolving the leak.The repairs were verified per established service procedures.Beckman coulter internal identifier for this report is (b)(6).

Event Description

The customer reported observing a blue colored fluid leak in their coulter lh 500 hematology analyzer that was not contained within the instrument and was approximately 15ml in volume.There was no biohazard exposure to mucous membranes or open wounds.The operator was wearing a lab coat, gloves and eye protection when the leak was discovered.Quality controls (qc) recovered within acceptable limits, all within specification.There was no death, injury, or change to patient treatment and no erroneous results were generated in connection with the reported event.

• Brand Name: COULTER LH 500 HEMATOLOGY ANALYZER
• Type of Device: COULTER LH 500 HEMATOLOGY ANALYZER
• 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: 5324153
• MDR Text Key: 34269680
• Report Number: 1061932-2015-01871
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: AK22178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• 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