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

Catalog Number 178833

Device Problems Leak/Splash (1354); Ambient Temperature Problem (2878)

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

Event Date 06/27/2014

Event Type  malfunction  

Event Description

The customer reported a leak from a coulter lh 500 hematology analyzer, which was not contained within the instrument.The customer stated the instrument generated ambient temperature errors when the leak was found.There were no erroneous results generated and there was no impact to patient treatment in connection with the leak.The instrument operator was wearing gloves and a lab coat at the time of the leak.There were no reports of direct contact with the leak or of injury as a result of the leak.

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument.The fse found a hole in the tubing through pinch valve pv37 and replaced the tubing to resolve the leak.Tubing through pv42 was also replaced as an incidental measure.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: 3951294
• MDR Text Key: 4627421
• Report Number: 1061932-2014-01689
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• 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: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2007
• 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