MAUDE Adverse Event Report: HALYARD HEALTH ON Q PUMP

Device Problems Device Operates Differently Than Expected (2913); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Pain (1994)

Event Date 07/18/2017

Event Type  Injury  

Event Description

The on q pump is a medical device used to decrease pain.I am an orthopedic surgeon, and i advise many of my patients to have this device placed by an anesthesiologist.Usually it works great.However, i have had several patients, including the one i am writing about now, who have had temporary failures of the device because of a design flaw.The device has a clear plastic cover over the dial that limits the rate of delivery of local anesthetic.If the plastic cover is not securely fastened, even opened a little, the pump will not work, and the patient will have markedly increased pain.Either the patients are leaving the pacu (recovery room) with the cover not closed properly or the cover opens up later.I have found a work around by asking patients or nurses to tape the cover closed.I try to educate people, but i can't educate everyone and the problem still occurs.The device probably needs to be redesigned, but there should at least be an intensive outreach and education and warning to users about this potential complication and a temporary work around until this design issue is resolved.This happened again last night.I got a call from the nurse about patient having severe pain in the arm after te block wore off.I asked her to check the cover, and she reported that it clicked close (was not completely closed).The pump began working again, and patient was comfortable the next day, but only after lots of unnecessary pain.Patient still has the on q pump.I can ask her to save it, if you wish.

• Brand Name: ON Q PUMP
• Type of Device: ON Q PUMP
• Manufacturer (Section D): HALYARD HEALTH
• MDR Report Key: 6731287
• MDR Text Key: 80779885
• Report Number: MW5071117
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2017
• 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 Outcome(s): Other
• Patient Age: 80 YR