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

Catalog Number 6605526

Device Problems Bent (1059); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

The customer reported the manual mode arm is bent and loose in a coulter hmx hematology analyzer with autoloader.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.There was no impact to patient results and controls.

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 06/01/2015.The fse confirmed the manual sampling probe was not attached properly to the blood sampling valve (bsv).The fse replaced the bsv resolving the issue.The repairs were verified per established service procedures.(b)(6).

• 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: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 4854449
• MDR Text Key: 5850763
• Report Number: 1061932-2015-01014
• 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: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• 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