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

Model Number	ANGEL CENTRIFUGE US (REFURBISHED)
Medical Device Problem Codes	Separation Failure (2547); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
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 04/14/2025, a sales representative reported via (b)(4) that an abs-10060r angel centrifuge never separated.This occurred during use, the prp never separated the blood and plasma, it all went into the bag.There were no adverse effects to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged abs-10060r serial number (b)(6) was returned for investigation.Functional testing results: 60ml of bovine blood with acd-a was processed on the device with standard settings at seven percent hematocrit.The device reported outputs of 33 ml platelet-poor plasma (ppp), 23 ml rbc, and 5 ml prp.The prp volume within the syringe was recorded as 4.5 ml.Aliquots of the wb and prp were analyzed for cbcs with the heska hematology analyzer (table 1).The complaint describes that the system in question, sn (b)(6), did not separate the blood components.In conclusion, this error could not be replicated.Visual evaluation noted no issues with the device.Manufacturing date 2023-01-30.No problem found.See attached testing investigation memo.Refer to investigation photos.The complaint allegation is not confirmed.

• 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: 21945012
• Report Number: 1220246-2025-01841
• Device Sequence Number: 8358784
• Product Code: ORG
• UDI-Device Identifier: 00888867249585
• UDI-Public: (01)00888867249585(10)15229216
• 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): 05/27/2025

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
• Device Lot Number: 15229216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown