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

Model Number CB004

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2018

Event Type  malfunction  

Event Description

On-q pump filled with ropivacaine 0.2% 400ml x 2 pumps dispensed on (b)(6) 2018 at around 10.00.Orders profiled in computer as 8ml/hr for each pump.On (b)(6) 2018 at 11:00, pt's rn stated that the pump on the right side was empty.Surgeon was made aware and clamped the pump.Lot number of clamped pump is 0202836602.Dates of use: (b)(6) 2018.Is the product compounded? yes; is the product over-the-counter? no.

• Brand Name: ON-Q PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 8069000
• MDR Text Key: 127207763
• Report Number: MW5081190
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/08/2018

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 Model Number: CB004
• Device Lot Number: 0202836602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 138