MAUDE Adverse Event Report: ARTHREX, INC. ANGEL CPRP PROCESSING SET USM; PLATELET AND PLASMA SEPARATOR

Model Number	ANGEL CPRP PROCESSING SET USM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2025
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 (b)(6) 2025, a sales representative reported) (4) that an abs-10063 prp processing set failed to process.This occurred during a case where they pulled bma to concentrate in the angel centrifuge, the first time the machine tried to draw the blood up and could not fill the angel, they emptied the angel and tried to refill the angel.Then opened another angel kit to try and process the blood to get the concentrated bone marrow out, the same issue occurred and the angel said there was air detected and would not complete the spin.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 was able to conclude a most likely cause.The most likely cause can be attributed to user error due air in the disk bag caused by improper insertion of the cassette.

• Brand Name: ANGEL CPRP PROCESSING SET USM
• Common Device Name: PLATELET AND PLASMA SEPARATOR
• 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: 21345852
• Report Number: 1220246-2025-00343
• Device Sequence Number: 7835047
• Product Code: ORG
• UDI-Device Identifier: 00888867084001
• UDI-Public: 00888867084001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/26/2025

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 CPRP PROCESSING SET USM
• Device Catalogue Number: ABS-10063
• Device Lot Number: 2023060223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown