MAUDE Adverse Event Report: ARTHREX ARTHREX DUALWAVE IRRIGATION PUMP

Device Problem Decrease in Pressure (1490)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 06/23/2017

Event Type  Injury  

Event Description

Surgical team noticed that the arthrex pump developed a loud cycling noise and that the pump sounded like it was running faster than the programmed pressure of 80.The circulator assessed the pump, pump tubing and the surgeon asked the circulator to reduce the pressure to 50.The circulator completed the reduction of the pressure to 50 and the surgical team noted that the unit continued to sound like it was cycling faster than the set pressure.The unit was turned off by the circulator, repositioned the pump tubing into the unit for problem solving, the unit was turned on set pressure to 50.The unit cycled properly without the fast noise previously heard by the surgical team.The surgery was completed without further incident.Dressing was applied by the surgeon.The drapes and accufex leg holder were removed and the surgical team noted that the right leg/thigh and right lower abdominal quadrant was swollen with discoloration on right upper thigh, deep red.The doppler was brought into the room and pedal pulses were assessed, present.Patient awakened, following commands and movement of right leg assessed with good movement in both legs.

• Brand Name: ARTHREX DUALWAVE IRRIGATION PUMP
• Type of Device: ARTHREX DUALWAVE IRRIGATION PUMP
• Manufacturer (Section D): ARTHREX; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 6672995
• MDR Text Key: 78716285
• Report Number: MW5070664
• Device Sequence Number: 1
• Product Code: HRX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 57