MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q PAIN PUMP; PUMP, INFUSION, ELASTOMERIC

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Overdose (1988); Numbness (2415); Sleep Dysfunction (2517); Decreased Sensitivity (2683)

Event Type  No Answer Provided  

Event Description

An (b)(6) y/o female who underwent a total knee replacement had an adductor canal block and catheter placed for post-op analgesia.She was discharged home with the catheter in place and attached to an on q pain pump (avanos medical).In the middle of the night around midnight she woke from sleep and her entire surgical leg was numb with loss of proprioception and motor function.No systemic toxicity symptoms.At that time she stopped the pump and a relative clamped it with a paper clip.She was instructed to remove the catheter and a few hours after doing so the sensation returned to that leg.No more sequelae occurred.The device was shipped back to us at the hospital.The ball of ropivacaine 0.2% appears to be totally empty.We are concerned that the device malfunctioned and would like it to be examined by you for this issue.(b)(4).

• Brand Name: ON-Q PAIN PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 9677037
• MDR Text Key: 178175773
• Report Number: MW5092810
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2020
• Patient Sequence Number: 1