MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number N/A

Device Problems Electrical /Electronic Property Problem (1198); Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 03/13/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2016 the field service engineer (fse) found pinch valve pv49 broken which caused the leak and diluent errors.Pv49 was replaced to fix the leak and errors.The fse noted poor latron recovery with dc voltage gains out of range.The laser was cleaned and the flowcell aligned to resolve the issue.The repairs were verified per established procedures.(b)(4).

Event Description

The customer reported a contained diluent leak of less than 10 ml from the coulter lh500 hematology analyzer.There were diluent comparison out 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 LH500 HEMATOLOGY ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami 33196 ; 3053802031
• MDR Report Key: 5545728
• MDR Text Key: 41819375
• Report Number: 1061932-2016-00271
• 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: 03/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178833
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1