MAUDE Adverse Event Report: BECKMAN COULTER CYTOMICS FC 500 MPL FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Catalog Number 626554

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

During instrument service, the field service engineer (fse) reported the tubing to the probe switching valve came off at the sheath inlet port resulting in a fluid leak involving the cytomics fc 500 mpl flow cytometer.No erroneous patient results were generated.There was no patient impact associated with this event.The fse was wearing personal protective equipment (ppe) consisting of gloves and a laboratory coat.There was no operator injury or adverse effect associated with this event.The fse noted the lee valve was blocked at the sheath tube inlet creating a back pressure which caused the tube to come off the fitting.The fse replaced the probe switching valve and resolved the issue.No system error codes were generated.The facility has an exposure control and risk management plan in place for biohazard material.

Manufacturer Narrative

(b)(4).

• Brand Name: CYTOMICS FC 500 MPL FLOW CYTOMETER
• 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: 3911234
• MDR Text Key: 4514882
• Report Number: 1061932-2014-01537
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K071681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 626554
• Other Device ID Number: SOFTWARE VERSION 2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2010
• 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