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

Model Number	ANGEL CENTRIFUGE US (REFURBISHED)
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The complaint allegation was confirmed.The reported failure was replicated.One unpackaged abs-10060r angel centrifuge us (refurbished) serial/batch number (b)(6) was received for evaluation.A visual evaluation notes cosmetic damage to the housing, such as scratches, marks, and 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 complaint describes that the system in question, sn (b)(6), would repeatedly restart without ever processing.This error was replicated.The disposable was loaded, blood was injected into the whole blood bag, and once a cycle was initiated, the unit restarted.This occurred three times.The device was then manually power cycled.The error continued to occur; therefore, no blood testing was able to be conducted.The most likely cause of the reported failure is wear and tear from the device due to use.Device manufacturing date: 04/11/01.
Event or Problem Description
Additional information was provided on 03/06/2025 where the representative stated they were scheduled to use the new system for the intraperitoneal catheters which is called the angel system.It is what prepares the prp.The anesthesiologist attempted to withdraw over 50cc of the patient¿s blood and was not successful.Only 50 was collected, after multiple attempts by the anesthesiologist.The blood collection was connected to the device and no prp was produced after the cycle.Dr.Marsh was made aware and was present during the collection and processing of the blood.They concluded the procedure without the use of the prp.
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 facility representative reported via (b)(6) that an abs-10060r angel centrifuge will start a procedure, then it will stop and begin again without completing.This issue was discovered during a surgery, the blood collection did not produce prp, the doctor was made aware, the procedure was concluded without the use of prp.

• 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: 21619325
• Report Number: 1220246-2025-00977
• Device Sequence Number: 6668478
• Product Code: ORG
• UDI-Device Identifier: 00888867249585
• UDI-Public: (01)00888867249585(11)130918(10)NB
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2013
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown