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

Catalog Number 6605526

Device Problems Loose or Intermittent Connection (1371); Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/15/2014

Event Type  malfunction  

Event Description

The customer reported control values (5c abnormal level i out of range high and normal level recovering low) when using the coulter hmx hematology analyzer with autoloader.The customer identified that the blood sampling valve was loose and unable to be tightened.A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the instrument.There were no erroneous test results associated with this event.There was no death, injury or affect to the user or patient associated with this event.

Manufacturer Narrative

On (b)(4) 2014, the field service engineer (fse) evaluated the instrument and observed the rbc (red blood cell) controls were recovering low after calibration.The fse replaced the rbc and wbc (white blood cell) dispensers, bsv (blood sampling valve), piercing needle for the primary mode, and all medical grade aspirate tubing.The fse flushed the aspirate line from pinch valve 70 (pv70) to the overflow tank in the rear of the instrument.Per conversation with the fse on (b)(4) 2014, the replacement of the bsv and proper setup of the aspiration pathway resolved the issues and calibration verified the changes and resolved the issues.(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: 3749769
• MDR Text Key: 14878503
• Report Number: 1061932-2014-00809
• 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: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• 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: 2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• 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