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

Catalog Number 6605632

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Chemical Spillage (2894)

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

Event Date 04/14/2014

Event Type  malfunction  

Event Description

The customer reported a leak of approximately 1 milliliter of diluent from a loose tubing at a port (fitting) on the blood sampling valve (bsv) of the coulter® lh 750 hematology analyzer.The customer indicated that the leak was not contained within the instrument.The customer was wearing personal protective equipment consisting of gloves and a laboratory coat at the time of the event and there was no report of injury or direct exposure to the leak.Erroneous results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

Customer technical specialist (cts) assisted the customer with troubleshooting over the telephone.The customer secured a loose tubing onto the port of the bsv to resolve the issue.A field service engineer (fse) was not dispatched to the customer's site for this event as the customer was able to resolve the issue with the assistance of the cts over the telephone.In conclusion, failure mode of the event is attributed to a loose tubing at the bsv.(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 boulevard; brea, CA 92821 ; 7149614941
• MDR Report Key: 3806416
• MDR Text Key: 16801815
• Report Number: 1061932-2014-00939
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605632
• Other Device ID Number: SW VERSION 2D3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2014
• 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