MAUDE Adverse Event Report: ARTHREX, INC. MAIN PUMP TUBING; ARTHROSCOPE

Model Number MAIN PUMP TUBING

Device Problems Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problems Extravasation (1842); Swelling/ Edema (4577)

Event Date 01/10/2023

Event Type  Injury  

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.

Event Description

It was reported on 01/11/2023 by a arthrex employee via sems that an ar-6410 main pump tubing flow became unstable and the patients shoulder was swollen.The surgery was completed with a new ar-6410.Postoperative examination revealed swelling of the patient's chest, back, upper arms, and neck.

Manufacturer Narrative

Complaint is confirmed.One unpackaged ar-6410 serial/batch number 40060953 was received for investigation.Functional testing not performed due to the damaged in the neoprene sleeve.Visual evaluation found the neoprene sleeve has collapse.Among the most common causes for this type of issue/occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.

• Brand Name: MAIN PUMP TUBING
• Type of Device: ARTHROSCOPE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16263478
• MDR Text Key: 308357157
• Report Number: 1220246-2023-06182
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: 00888867118010
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAIN PUMP TUBING
• Device Catalogue Number: AR-6410
• Device Lot Number: 40060953
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other