MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument.The fse found that valve vl161 was faulty.The fse replaced the valve, which repaired the leak.The repairs were verified by the fse.(b)(4).

Event Description

The customer reported a bloody leak from the unicel dxh 800 coulter cellular analysis system.The volume of the leak was not specified and was not contained within the instrument.The fse was wearing personal protective equipment (ppe) consisting of gloves, goggles and a laboratory coat at the time of the event.There was no report of injury or biohazard exposure to open wounds or mucous membranes.Erroneous results were not generated.There was no change in patient treatment.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami 33196 ; 3053802031
• MDR Report Key: 5993550
• MDR Text Key: 56194292
• Report Number: 1061932-2016-00868
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• 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: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 629029
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1