MAUDE Adverse Event Report: BECKMAN COULTER COULTER® LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605632

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

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

Event Date 02/21/2014

Event Type  malfunction  

Event Description

A customer reported that, after running controls at startup, they received retic control vote outs on the lh750 instrument.A field service engineer (fse) was dispatched.When the fse arrived on site, he noticed a leak of blue violet fluid from disconnected tubing that had popped off a check valve (cv103b).The volume was reported as 20 ml and the leak was not contained.No erroneous patient results were generated in connection with this event.

Manufacturer Narrative

The field service engineer (fse) replaced the tubing that had popped off at check valve 103 b and the check valve to resolve the leak.Sample lines and a t fitting were also replaced to resolve the low retic values recovered on the controls.(b)(4).

• Brand Name: COULTER® LH 750 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: 3673600
• MDR Text Key: 4345695
• Report Number: 1061932-2014-00545
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2005
• 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