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

Model Number	ANGEL PRP SYSTEM CENTRIFUGE US (NEW)
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an abs-10060 angel centrifuge was unable to spin and separate.This occurred during a case, where the centrifuge was unable to spin and separate.They reported bubbles getting mixed in with the blood.There were no error alerts present.The surgeon did have to draw blood and re-spin again with no success.The case was only delayed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged abs-10060 serial number (b)(6) was returned for investigation.Functional testing with 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), had incomplete separation.Furthermore, bubbles were observed in the blood.During testing, an unfamiliar noise was being produced during spinning.However, this error could not be replicated.The device reported outputs of 41ml platelet-poor plasma (ppp), 16ml rbc, and 3ml prp.The prp volume within the syringe was recorded as 3.2ml.Aliquots of the wb and prp were analyzed for cbcs with heska hematology analyzer (table 1).Please note that the prp had expected cellular foldx concentrations.The most likely cause for the reported failure can be attributed to user error of the device as an improper type or amount of anticoagulant is consistent with the observations.

• 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: 20463168
• Report Number: 1220246-2024-08167
• Device Sequence Number: 12732662
• Product Code: ORG
• UDI-Device Identifier: 00888867083974
• UDI-Public: 00888867083974
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/03/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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