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

Catalog Number 6605526

Device Problems Bent (1059); Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317)

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

Event Date 12/08/2014

Event Type  malfunction  

Event Description

The customer reported an uncontained clear fluid leak of approximately one (1) ml during each cycle from the bottom of the blood sampling valve (bsv) of the coulter hmx analyzer with autoloader.The leak was a mixture of blood, diluent, lyse, stain and clenz reagent, and was observed during startup.The customer stated the manual aspiration probe appeared to be bent, and the operator was unable to press the manual mode start lever as it would jam the probe.There was no report of injuries, erroneous results, direct physical contact with the leak, or change to patient treatment in connection with this event.The customer was wearing gloves and laboratory coat when the leak occurred.A beckman coulter (bec) field service engineer (fse) was dispatched to the customer site to evaluate the instrument.

Manufacturer Narrative

The fse found the bent probe prevented the probe rinse block (rb1) to move.The fse straightened the bent probe to resolve the issue.The fse then performed verification of the instrument to meet the specified requirements per established procedures.

• Brand Name: COULTER HMX 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: 4361118
• MDR Text Key: 16861841
• Report Number: 1061932-2014-03089
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• 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: SOFTWARE VERSION 1.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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