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	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/26/2024, it was reported by a sales representative via (b)(4) that an abs-10060 angel machine.Failed to ¿separate¿ autologous fluid into its designated spots.The angel machine dumps all fluid back into the ¿whole blood in¿ section of the angel cassette bags.This occurred during a case where the patient did not receive the bma as it did not get separated in angel.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation was not confirmed.One unpackaged abs-10060 angel prp system centrifuge serial/batch number (b)(6) was received for investigation.Upon visual inspection, the returned device showed signs of wear and tear around the housing.The 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), was not properly separating into the disposable compartments.Instead, all contents returned to the ¿whole blood in¿ compartment.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: 19992852
• Report Number: 1220246-2024-07178
• Device Sequence Number: 12877071
• Product Code: ORG
• UDI-Device Identifier: 00888867083974
• UDI-Public: 00888867083974
• 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): 09/13/2024

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: 10004739
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/13/2024
• 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