MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY CW4 ARTHROSCOPY PUMP; ARTHROSCOPE

Model Number SYNERGY CW4 ARTHROSCOPY PUMP

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2021

Event Type  malfunction  

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

Consigned cw4 pump used during an arthroscopic meniscal repair procedure.Pump started pumping fluid into the knee at a very rapid rate causing the pressure to rise in the patients knee.Nursing staff stopped the pump and turned it back on after a few seconds.Pumped work fine for a minute then started pumping fluid at a rapid rate again.From then onwards, they turned pump on and off manually to complete the procedure.The cw4 is consigned to crest hospital.

Manufacturer Narrative

The manufacturer's evaluation could not confirm the complaint since the returned condition of the unit is unknown.

• Brand Name: SYNERGY CW4 ARTHROSCOPY PUMP
• 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: 12570649
• MDR Text Key: 274694722
• Report Number: 1220246-2021-03729
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: 00888867251182
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K024291
• 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: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYNERGY CW4 ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6485
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other