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

Catalog Number 723585

Device Problem Charred (1086)

Patient Problem Not Applicable (3189)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

The fse found that the diluter 2 card had malfunctioned and burnt out charring some components.The fse replaced the card, which repaired the burning smell and the errors.The repairs were verified per established procedures.(b)(6).

Event Description

The field service engineer (fse) reported a burning smell from the coulter lh 780 hematology analyzer when servicing the instrument.The instrument was generating probe wipe obstruction errors when the burning smell was noticed.There were no sparks, arcs, flames or smoke observed and the fire department was not called.The fse was wearing personal protective equipment (ppe) consisting of gloves, eye protection and a laboratory coat at the time of the occurrence.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

The device manufacture date was changed from 02/01/2015 to 02/01/2008.

• 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: 5158027
• MDR Text Key: 28563415
• Report Number: 1061932-2015-01596
• 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: Followup
• Report Date: 09/21/2015

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: Health Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• 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