MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS ONQ PUMP 600ML ; PUMP, INFUSION, ELASTOMERIC

Lot Number 0002999004

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 10/03/2019

Event Type  malfunction  

Event Description

Device was ordered and filled to max dose of 750ml at 8cc/hr (93 hour infused time).It was found to have infused over 2 days instead of intended 4 days.No injury to pt.

• Brand Name: AVANOS ONQ PUMP 600ML
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. ; 5405 windward pkwy; alpharetta GA 30004
• MDR Report Key: 9418075
• MDR Text Key: 169514668
• Report Number: MW5091469
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2019

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 Operator: Health Professional
• Device Lot Number: 0002999004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2019
• 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 Age: 51 YR