MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 723585

Device Problems Leak/Splash (1354); Output Problem (3005)

Patient Problem Not Applicable (3189)

Event Date 10/22/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument.The fse found that the actuator for valve vl98 was sticking.The fse replaced valve vl98, which repaired the leak.The customer had found that the vacuum trap jar was full.They had emptied the vacuum trap jar, which resolved the low vacuum errors.The repairs were verified by the fse.(b)(6).

Event Description

The customer reported a leak from the coulter lh 780 hematology analyzer.The instrument was generating low vacuum errors at the time of the event.The volume of the leak was about 20 ml and was not contained within the instrument.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat and gloves at the time of the event.There was no report of injury or biohazard exposure to open wounds or mucous membranes.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

• Brand Name: COULTER LH 780 HEMATOLOGY ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami, FL 33196 ; 3053802031
• MDR Report Key: 6108865
• MDR Text Key: 60089715
• Report Number: 1061932-2016-00968
• 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: 10/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• 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