MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605500

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the analyzer on 09/29/2016, and indicated that the customer resolved the leak prior to the on-site service visit.The residual fluid on the sample tubes was attributed to the black plastic cap on port number 3 of the vic (vacuum isolator chamber) which fell off from the port, causing the vacuum to the probe wipe rinse block to drop, contributing to the leak.The fse inspected the analyzer and verified the plastic cap was properly reseated by the customer.(b)(4).

Event Description

A customer reported finding an uncontained leak of about 5cc of fluid on top of the sample tubes of a coulter ac t diff 2 analyzer while processing samples.The customer was wearing personal protective equipment (ppe) consisting of gloves and a laboratory coat when the leak was found, 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 affect to patient treatment in connection with this event.

• Brand Name: COULTER AC·T DIFF 2 ANALYZER
• 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: 6048968
• MDR Text Key: 58142585
• Report Number: 1061932-2016-00879
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990352
• 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
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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