MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER

Catalog Number 6605632

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was dispatched on 11/30/2015.The fse confirmed loose pressure tubing through pinch valve vl53 caused the leak.The fse replaced the tubing resolving the issue.The instrument ran without further issues and all repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported less than 3 mls of uncontained blue fluid leaked from the left side of the coulter lh 750 hematology analyzer onto the counter while cycling controls.There were no error messages reported by the customer at the time of the event.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.There was no impact to patient results and controls.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat, goggles and gloves at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Type of Device: COULTER LH 750 HEMATOLOGY ANALYZER
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5316041
• MDR Text Key: 34043118
• Report Number: 1061932-2015-01860
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2004
• 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