• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX ARTHREX DUALWAVE IRRIGATION PUMP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHREX ARTHREX DUALWAVE IRRIGATION PUMP Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARTHREX DUALWAVE IRRIGATION PUMP
Type of DeviceARTHREX DUALWAVE IRRIGATION PUMP
Manufacturer (Section D)
ARTHREX
1370 creekside blvd.
naples FL 34108
MDR Report Key6672995
MDR Text Key78716285
Report NumberMW5070664
Device Sequence Number1
Product Code HRX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-