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

Catalog Number 178833

Device Problems Fluid/Blood Leak (1250); Ambient Temperature Problem (2878)

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

Event Date 07/09/2014

Event Type  malfunction  

Event Description

The customer reported approximately 10 mls of fluid leaked from the coulter lh 500 hematology analyzer onto the counter.The leak was not contained within the instrument.The customer stated that the ambient/lyse temperature errors were also generated.There was no exposure to open wounds or mucous membranes.The customer was wearing personal protective equipment (ppe) consisting of gloves, glasses and a lab coat at the time of the occurrence.No erroneous results were generated in connection with the reported event.There was no death, injury, or affect to user or to patient treatment attributed to this event.

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument.The fse observed a cut at the fitted sample line tubing connected to the peltier module and the differential mixing module.The fse replaced the line tubing at the peltier module which resolved the leak.The fse replaced the fuse due to the 2.5 amplifier fuse on the pneumatic power supply had blown.The fse also observed the 24 volt was not measured on the electronic power supply due to the fluid had leaked onto the differential mixing module.The sample was unable to mix due to the motor was not turning.The fse installed a new differential mixing motor which allows the sample to mix properly.The instrument was generating abnormal ii control vote outs.The fse increased the volume of the differential lyse introduced into the chamber due to weak lyse.The fse verified the instrument and the instrument was returned to normal operation.(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: 3965411
• MDR Text Key: 4560001
• Report Number: 1061932-2014-01771
• 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: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 178833
• Other Device ID Number: SW VERSION: 2A6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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