MAUDE Adverse Event Report: ARTHREX, INC. ANGEL PRP SYSTEM CENTRIFUGE US (NEW)

Model Number	ANGEL PRP SYSTEM CENTRIFUGE US (NEW)
Medical Device Problem Codes	Device Alarm System (1012); False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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 01/07/2025, it was reported by a sales representative via (b)(4) that an abs-10060 angel centrifuge was producing an "air in line error".This occurred during use.Additional information was provided on 01/10/2025 by the sales representative via (b)(4) where it was stated that this event occurred during a cardiothoracic prp case on (b)(6)2025 that was not completed.An abs-10061t arthrex angel® prp kit was being utilized during this event.
Additional Manufacturer Narrative
The complaint allegation was not confirmed.The reported failure couldn't be replicated.One unpackaged abs-10060 angel prp system centrifuge us serial/batch number (b)(6) was received for evaluation.A visual inspection reveals no significant cosmetic damage, only typical signs of wear and tear.Functional testing was performed by connecting the device and functional testing to see if the reported failure could be replicated.The device was shipped to naples, fl, for evaluation.60ml of bovine blood with acd-a was processed on the device with standard settings at seven percent hematocrit.The complaint describes that the system in question, sn (b)(6), displayed an ¿air in line¿ error.This error could not be replicated.No problem found.

• Brand Name: ANGEL PRP SYSTEM CENTRIFUGE US (NEW)
• 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: 21294659
• Report Number: 1220246-2025-00141
• Device Sequence Number: 7585974
• Product Code: ORG
• UDI-Device Identifier: 00888867083974
• UDI-Public: (01)00888867083974(11)240626(10)155886
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/02/2025

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 PRP SYSTEM CENTRIFUGE US (NEW)
• Device Catalogue Number: ABS-10060
• Device Lot Number: 155886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2024
• 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