MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF ANALYZER

Catalog Number 6706366

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on (b)(6) 2015 and found the wbc bath was not draining properly causing the reported issues - bath overflow and wbc aperture alerts.The fse found the wbc bath drain line tubing at vl14 kinked causing the wbc bath to not properly drain.The fse properly secured / rerouted this tubing allowing the wbc bath to properly drain resolving the reported issues.The fse performed verification of the instrument to meet the specified requirements per established service procedures.The beckman coulter internal identifier for this report is (b)(4).

Event Description

The customer reported their coulter ac·t diff analyzer was leaking about ½ cup of fluid onto the countertop and generated white blood count (wbc) aperture alerts (messages).There was no biohazard exposure to mucous membranes or open wounds.The customer was wearing her gloves at the time they discovered the leak.There was no death, injury, or change to patient treatment and no erroneous results were generated in connection with the reported event.

• Brand Name: COULTER AC·T DIFF ANALYZER
• Type of Device: COULTER AC·T DIFF ANALYZER
• 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: 5320222
• MDR Text Key: 34168187
• Report Number: 1061932-2015-01868
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973634
• 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: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 6706366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2004
• 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