MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS ON-Q PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number CB006

Patient Problems Muscle Weakness (1967); Tachycardia (2095); Numbness (2415); Alteration in Body Temperature (4568)

Event Date 12/14/2023

Event Type  Other  

Event Description

Avanos onq pump (select-a-flow, on-demand, model cb006) had faulty demand dose button.The patient was discharged after surgery on (b)(6) 2023 with an onq pump.That night she pressed the demand dose button and it stayed down, despite efforts to pry the button back up.She reported the medication ran continuously for 2-3 minutes and her arm felt progressively numb and weak, and her body felt warm and her heart rate was fast.Her husband used scissors to cut the pnc (peripheral nerve catheter) line.They presented to the emergency room to have pnc removed and replaced.Per avanos representative, the button should pop up instantaneously after being pressed.This was brought to the attention of our avanos representative and the pump was sent to them for investigation.This is the 4th patient cases of product malfunction in the span of 1 month at our hospital.

• Brand Name: AVANOS ON-Q PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 18536860
• MDR Text Key: 333347138
• Report Number: MW5150493
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 01/12/2024

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: Lay User/Patient
• Device Model Number: CB006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American