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

Catalog Number 6605632

Device Problems Thermal Decomposition of Device (1071); Device Displays Incorrect Message (2591)

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

Event Date 01/23/2014

Event Type  malfunction  

Event Description

The customer reported latron controls were failing for retics on the lh750 analytical station.The customer later noted an electrical burning smell after attempting to troubleshoot the issue.(b)(4) revealed the instrument generated 3 events +15 volts diff power supply outside limits errors.There was no fire, spark, arc or smoke observed for this event.In addition, no erroneous patient results were generated in connection with the reported event.

Manufacturer Narrative

The customer technical specialist (cts) instructed the customer to perform "function f93" to attempt to resolve the retics failing on the latron controls.The field service engineer (fse) confirmed that the customer performed "function f93" cleaning the retic shear valve (vl93/128) and used distilled water to subsequently flush the area.It was after the cleaning was performed that the customer observed the +15 volts diff power supply outside limit errors and the burning smell.As a result of the cleaning procedure the ls (light scatter) preamp got wet and was damaged.The fse replaced the ls preamp and adjusted the diff and retic gains resolving the issue and the burning smell.Shear valve cvl93/128 was also replaced.(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 blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 3631070
• MDR Text Key: 3986941
• Report Number: 1061932-2014-00379
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/23/2014

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: 6605632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2004
• 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