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

Catalog Number 178833

Device Problems Fluid/Blood Leak (1250); Temperature Problem (3022)

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

Event Date 11/17/2014

Event Type  malfunction  

Event Description

The customer reported a leak above the peltier module of a coulter lh 500 hematology analyzer which occurred when reagents were priming.The volume of the leak was less than 12 ml and was not contained within the instrument.The customer also reported the instrument generated temperature errors.The instrument operator was wearing gloves, a lab coat, and eye protection at the time of the leak.There were no reports of biohazard exposure to the leak.There were no erroneous results generated and patient treatment was not impacted in connection with this event.

Manufacturer Narrative

Beckman coulter (bec) customer technical support (cts) troubleshooted the leak with the customer via telephone.The customer found a leak in tubing at pinch valve pv37.Cts assisted the customer in replacement of the tubing, which resolved the leak.The leak had damaged the peltier module and mix chamber, which caused the peltier module to fail.A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument.The fse cleaned and dried the peltier assembly connections, which resolved the temperature errors.The fse found the mix chamber drive assembly was not mixing and replaced the part to resolve the mix motor failure.The instrument was able to run without leaks or errors.Repairs were verified per established procedures.(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: 4310982
• MDR Text Key: 5210192
• Report Number: 1061932-2014-02967
• 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: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• 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: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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