MAUDE Adverse Event Report: BECKMAN COULTER COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

Catalog Number 6605526

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument on (b)(4) 2015.The fse found and replaced tubing at pinch valve pv49 to resolve leak the repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported that 20 cc of clear fluid leaked from the coulter hmx hematology analyzer with autoloader onto counter top while processing samples the customer was wearing personal protective equipment (ppe) consisting of laboratory coat, eye glasses, and gloves at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.

Manufacturer Narrative

Device manufacturing date was revised to reflect the correct date.

• Brand Name: COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
• Type of Device: COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5296753
• MDR Text Key: 33468668
• Report Number: 1061932-2015-01833
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 6605526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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