MAUDE Adverse Event Report: BECKMAN COULTER AUTOMATE 2500 SAMPLE PROCESSING SYSTEM; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number ODL25250

Device Problem Device Handling Problem (3265)

Patient Problems Exposure to Body Fluids (1745); Laceration(s) (1946)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

The age or date of birth and weight were not supplied.Based on the information available, there is no evidence of a product or device malfunction.The information reasonably suggests a user error occurred since appropriate ppe were not in place while the bec employee was servicing and troubleshooting the device.Furthermore; if troubleshooting is being performed with open doors and covers, patient samples should be removed.Otherwise, covers must be closed during normal operation.As per automate 2500 family instructions for use (reference pn b50901) and service manual (revision 3) safety instructions: close covers during normal operation: while the system is operating, do not touch any moving robot.Make sure that all covers and doors are closed during operation.Avoid contact with sample material: do not touch patient samples, disposable tips, removed caps, any machine components that come in contact with the sample material, or waste liquid with your bare hands.Always wear gloves and other appropriate protective gear to protect yourself from infection.Before troubleshooting the system with open doors and covers, remove patient samples.

Event Description

A beckman coulter (bec) technical support employee, reported whilst replacing a drawer unit on an automate 2500 sample processing system serial number (b)(4) at a customer's site, suffered cuts to his hands due to sharp edges.The bec employee reported appropriate personal protective equipment (ppe) such as gloves were not in use.Afterwards the system started operating and tried to place uncapped samples into the racks that were not present as they were removed by another operator at the customer's site.Following, the bec technical support employee attempted to prevent spillage of samples and reached out to catch the tubes, spilling serum onto hands that had previously been cut.The bec employee halted the system immediately and was directed to the accident and emergency (a&e) unit in at the customer's site hospital.The a&e department contacted the bec employee's general physician (gp); however were unable to determine record of last hepatitis vaccination.The a&e department administered a booster shot for hepatitis, and gave direction for the gp through a letter requesting follow up jabs at 3 months and 6 months.Additionally two blood samples were collected at the a&e department around 4 hours after the incident for additional base line testing.The bec technical support employee confirmed following up with the gp on next day of friday (b)(6) 2016 and discussion of the incident in details.To date, no further effect was reported to bec in association with this event.

• Brand Name: AUTOMATE 2500 SAMPLE PROCESSING SYSTEM
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; ruppert-mayer-str. 44; munchen, 81379 ; GM 81379
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821 ; 7142649714
• MDR Report Key: 5517933
• MDR Text Key: 40929449
• Report Number: 3006655511-2016-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ODL25250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2006
• 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
• Patient Outcome(s): Required Intervention