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	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/19/2023, it was reported by a sales representative via (b)(4) that an abs-10063 cprp processing set didn't siphon off the different cells at the end of the cycle, and blood spilled after attempting to remove the disc set from an abs-10060r angel centrifuge.No further information was reported.Additional information has been requested.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint is confirmed.The device was not returned for investigation and an evaluation was performed based on the pictures provided.Upon picture evaluation attached to the complaint of an abs-10063 cprp processing set, batch number 2023050421.It was observed that the angel processing set was attached to the angel centrifuge machine, and there was blood spillage around the device.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.Per dfu-0259-4 revision 0 - warning at section 8 - refer to the angel concentrated platelet-rich plasma (cprp) system operator¿s manual for unloading a variable volume separation chamber containing blood.- dfu-0262-3 at revision 0.Installing the angel cprp processing set.Improper installation of the separation chamber will result in damage.If the separation chamber plate is not properly secured inside the centrifuge chamber, safety wings along the edge of the centrifuge will not retract.The complaint has been confirmed.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18163075
• Report Number: 1220246-2023-08789
• Device Sequence Number: 7321903
• Product Code: ORG
• UDI-Device Identifier: 00888867084001
• UDI-Public: 00888867084001
• 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): 11/22/2024

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 Expiration Date: 04/30/2026
• Device Model Number: ANGEL CPRP PROCESSING SET USM
• Device Catalogue Number: ABS-10063
• Device Lot Number: 2023050421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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