MAUDE Adverse Event Report: BECKMAN COULTER, INC. POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE; RADIOASSAY, VITAMIN B12

Model Number	3.0 PP BASIC TRK ONE OUTLET
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was referred to the er (emergency room) due to finger injury.A metal shaving entered the fse finger when lubricating the belts of power processor basic track one outlet during preventative maintenance.Based on the information provided the er doctor administered a tetanus shot and ordered x-rays of finger.The metal shaving was removed from finger, no further medical attention required.No medications were prescribed.There was no evidence of a system malfunction.The cause of injury was an accidental injury during routine pm.The fse did not have to miss work due to this injury.No further harm was reported.A2, a3, a4, a5: no patient involvement.The beckman coulter identifier is (b)(4).
Event or Problem Description
A beckman coulter field service engineer (fse) reported sustaining an in injury to his finger when performing preventative maintenance on their power processor basic track one outlet.The fse indicated that while lubricating belts during a pm task, a small metal sliver shaving entered their finger.The injury was not immediately reported.The fse later sought medical attention due to pain and swelling in their right thumb.The fse was referred to the emergency room (em) where they were administered a tetanus shot as a result of injury.The fse also got an x-ray of his finger.The fse confirmed the metal shaving was gone after medical attention.No work was missed due to this incident, no medications were prescribed.No additional harm was reported.

• Brand Name: POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 21684566
• Report Number: 2050012-2025-00129
• Device Sequence Number: 15665986
• Product Code: CDD
• UDI-Device Identifier: 15099590591960
• UDI-Public: (01)15099590591960(11)130701
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: 3.0 PP BASIC TRK ONE OUTLET
• Device Catalogue Number: A11036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown