MAUDE Adverse Event Report: ARTHREX, INC. ANGEL CENTRIFUGE US (REFURBISHED)

Model Number	ANGEL CENTRIFUGE US (REFURBISHED)
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 01/17/2025, a sales representative reported via (b)(4) that an abs-10060r angel centrifuge eye/light sensor error won¿t go off.This occurred during a bmac procedure where the tubing was not loaded.They cleaned the sensor.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause for the reported failure can be attributed to user error, including: light sensor calibration: the ¿light sensor calibration¿ alarm is displayed if the platelet sensor is not able to calibrate itself.The three reasons this may occur are: (1) the user has not loaded the disposable set correctly, (2) the platelet sensor is dirty, or (3) the platelet sensor is too close to an external light source.(1) if the disposable set is not yet installed, install it according to the instructions in chapter 2: installing the disposables.Make sure that the platelet cuvette is securely in place and that the valve assembly is properly mounted.(2) if the alarm is still active, clean the platelet sensor, then reinstall the disposable set.(3) ensure that the platelet sensor is at least 1 meter (3 feet) from all external light sources.The complaint allegation was not confirmed, and no evidence of the failure was received.

• Brand Name: ANGEL CENTRIFUGE US (REFURBISHED)
• Common Device Name: CENTRIFUGE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21353969
• Report Number: 1220246-2025-00366
• Device Sequence Number: 8950330
• Product Code: ORG
• UDI-Device Identifier: 00888867249585
• UDI-Public: 00888867249585
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ANGEL CENTRIFUGE US (REFURBISHED)
• Device Catalogue Number: ABS-10060R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown