MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER

Catalog Number 723585

Device Problem Leak/Splash (1354)

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

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was onsite on 12/03/2015 and found that the tubing had popped off the blood sampling valve (bsv) at fitting 10.The fse replaced tubing from bsv to fitting 10.The instrument was verified to meet the specified requirements per established facility procedure.(b)(4).

Event Description

The customer reported approximately 2 l of an uncontained greenish blue fluid leaked from the coulter lh 780 hematology analyzer onto the floor while cycling patient samples.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 or controls.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat 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 780 HEMATOLOGY ANALYZER
• Type of Device: COULTER LH 780 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: 5325015
• MDR Text Key: 34303671
• Report Number: 1061932-2015-01873
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061616
• 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: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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