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

Model Number CB006

Patient Problem Insufficient Information (4580)

Event Date 12/02/2023

Event Type  malfunction  

Event Description

Avanos onq pump (select-a-flow, on-demand, model cb006) had malfunctioned - on day 3 of having onq pump, the patient claimed that the drug reservoir containing the 0.2% ropivacaine was not delivering any medication and has not changed size at all.The continuous rate was originally set to 8ml/hr with optional 5ml patient-bolus every 30mins; it is supposed to deflate as medication gets used up from the reservoir.This was brought to the attention of our avanos representative and the pump was sent to them for investigation.This is the second of four 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: 18536792
• MDR Text Key: 333348624
• Report Number: MW5150491
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• 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?: Yes
• 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
• Treatment: ROPIVACAINE
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White