MAUDE Adverse Event Report: ARTHREX, INC. ANGEL CPRP PROCESSING SET USM; PLATELET AND PLASMA SEPARATOR

Model Number ANGEL CPRP PROCESSING SET USM

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales representative via sems that an abs-10060r angel centrifuge had an issue.The doctor tried to do a regular prp, but prp never came out.They tried a second run, but everything came out, blood was spinning and spilling over the patient.Used a total of two kits to complete the case successfully.Two abs-10063 angel cprp processing sets broke down during the case.No adverse event to the patient or harm.Additional information has been requested.On (b)(6) 2023, the sales representative stated the following information over the phone: when the first angel kit was used, there was a problem with the prp output.The doctor then used the second angel kit, which also had a problem with the output.The abs-10060r angel centrifuge produced too much output during the second run, which caused the plunger of the prp syringe to fall out, but neither the patient nor the staff was exposed to bodily fluid, there was no harm.The procedure could not be finished.The patient was not under anesthesia.The patient came back another day, and another abs-10060r angel centrifuge was used with a new abs-10063 angel cprp processing set with the same lot number to complete the procedure successfully with no impact to the patient.On (b)(6) 2023, the sales representative provided the following information via phone: when the plunger of the prp syringe was pushed out when using the second angel kit, a little bit of blood spilled over the machine, but neither the patient nor the staff was exposed to bodily fluid.The staff wore gloves and used wipes to decontaminate the site per the normal decontamination protocol.

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.

• Brand Name: ANGEL CPRP PROCESSING SET USM
• Type of Device: 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: 17164491
• MDR Text Key: 318034629
• Report Number: 1220246-2023-06936
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00888867084001
• UDI-Public: 00888867084001
• 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
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANGEL CPRP PROCESSING SET USM
• Device Catalogue Number: ABS-10063
• Device Lot Number: 2022060125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2023
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1