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

Model Number ANGEL CENTRIFUGE US (REFURBISHED)

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2023

Event Type  malfunction  

Event Description

On (b)(6)2023, it was reported by a sales representative via sems that an abs-10060r angel machine did not produce any prp, ppp, or rbc.This occurred during a case, the centrifuge completed spin but did not produce any prp, ppp, or rbc.Blood stayed in the centrifuge plate of the disposable set, no manual motor work could expel anything from the disposable set into the collection syringe or bags.There was no patient effect reported.There was no additional information provided additional information requested.

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

Manufacturer Narrative

The complaint allegation was not confirmed.Refer to the memo for investigation results.No problem found.

• Brand Name: ANGEL CENTRIFUGE US (REFURBISHED)
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 17364173
• MDR Text Key: 319745511
• Report Number: 1220246-2023-07244
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00888867249585
• UDI-Public: 00888867249585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK110046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANGEL CENTRIFUGE US (REFURBISHED)
• Device Catalogue Number: ABS-10060R
• Device Lot Number: 11843811
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1