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

Catalog Number 178833

Device Problems Bent (1059); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 04/13/2014

Event Type  malfunction  

Event Description

Customer reported a leak when using the coulter lh 500 hematology analyzer.A few drops of fluid leaked from the blood sampling valve (bsv) in the instrument.The leak was contained.The customer also stated the probe was bent and the instrument was generating backwash failure errors.The operator was wearing personal protective equipment of lab coat and gloves when the leak was identified.There was no exposure to mucous membranes or cuts.There was no biohazard exposure reported.There were no erroneous test results associated with this event.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the instrument and confirmed the leak from the bsv (blood sampling valve) and the probe was bent.The fse replaced the bsv resolving the leak.This action also resolved the backwash failure error messages, which were generated to alert the customer to an instrument problem.(b)(4).

• 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; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: dung nguyen ; 250 s kraemer blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 3803295
• MDR Text Key: 4381024
• Report Number: 1061932-2014-01036
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• 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: 04/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2009
• 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