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

Catalog Number 6605632

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

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

Event Date 02/21/2014

Event Type  malfunction  

Event Description

The customer stated that the tubing popped off the sheath tank on the lh750 instrument and was leaking diluent.The leak was not contained and the volume was undetermined.There was no exposure to open wounds or mucous membranes.In addition, no erroneous results were generated in connection with the reported event.

Manufacturer Narrative

A field service engineer (fse) was dispatched.The fse found a leak at the upper sheath restrictor due to a tubing popping off.He replaced the green stripe tubing to the upper sheath restrictor.The instrument was cycled to prime the upper sheath restrictor pathway.The issue was resolved.(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: 3673605
• MDR Text Key: 21732576
• Report Number: 1061932-2014-00541
• 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: 02/01/2011
• 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