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

Model Number NOT APPLICABLE

Device Problems Break (1069); Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

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

Event Date 03/20/2014

Event Type  malfunction  

Event Description

The customer reported that retic stain leaked from the coulter lh 750 hematology analyzer when tubing popped off of a fitting and the instrument generated reticulocyte (retic) voteout after running a sample.There was no biohazard exposure to mucous membranes or open wounds.No erroneous results were generated for this event.

Manufacturer Narrative

Customer technical support (cts) was told by customer that she was able to reconnect tubing to the shear valve fitting (cvl93) to resolve the issues.Field service was not dispatched to site for this event.(b)(4).Customer resolved leak himself.

• 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: 3749904
• MDR Text Key: 4471457
• Report Number: 1061932-2014-00832
• 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: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: 6605632
• Device Lot Number: NOT APPLICABLE
• Other Device ID Number: SW VERSION: 2D3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2003
• 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