MAUDE Adverse Event Report: BECKMAN COULTER COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605526

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

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

Event Date 02/18/2014

Event Type  malfunction  

Event Description

The customer reported a burning odor coming when using the coulter hmx hematology analyzer with autoloader.The customer also reported the instrument generated multiple vdc (volts direct current) errors.The customer quickly powered off the instrument.No patient results were impacted.There was no fire or smoke and the customer did not observe sparks, arcs, or flames.The fire department was not called and a fire extinguisher was not used.There was no death, injury or affect to the user associated with this event.No one sought medical attention.

Manufacturer Narrative

On (b)(4) 2014, the field service engineer (fse) evaluated the instrument and could not confirm a burning odor.The fse was unable to boot up the instrument past the compressor signal.The fse replaced the diluter interface card allowing the instrument to boot up.While verifying instrument operation and unrelated to the burning issue, the fse found a blood clot blocking the flowcell and a minor tubing leak at pinch valve (pv) 40.The fse removed the clot in the flowcell, replaced the tubing through pv 40 and performed a ttm (triple transducer module) alignment resolving the issues.Failure mode of the leak is related to pv 40.The failure mode of the instrument unable to boot up was the diluter interface card.The instrument generated multiple vdc (volts direct current) errors alerting the customer to an instrument problem.The failure mode of the blocked flowcell is use error.The customer cycled a clotted specimen through the analyzer.Coulter hmx hematology analyzer with autoloader certificate of compliance lists the following: (b)(4).

• Brand Name: COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
• 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: 3676248
• MDR Text Key: 4294502
• Report Number: 1061932-2014-00555
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605526
• Other Device ID Number: 1.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2006
• 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