MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 723585

Device Problems Fluid/Blood Leak (1250); Aspiration Issue (2883)

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

Event Date 10/01/2014

Event Type  malfunction  

Event Description

The customer reported a leak from a coulter lh 780 hematology analyzer.The leak occurred from the bottom of the diluter near the left side.The volume of the leak was five to ten milliliters and was not contained within the instrument.In addition, the instrument generated partial aspiration errors.The instrument operator was wearing gloves and a lab coat 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

A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument.The fse found a hole in tubing at pinch valve vl9a.The fse replaced vl9a and the instrument ran without leaks or error messages.Repairs were verified per established procedures.(b)(4).

• Brand Name: COULTER LH 780 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: 4201009
• MDR Text Key: 4978957
• Report Number: 1061932-2014-02642
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061616
• 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: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 723585
• Other Device ID Number: SW VERSION 1B3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• 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