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

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  No Answer Provided  

Event Description

An event was reported in which an on-q pain relief system filled with bupivacaine 0.125% was connected to an iv piggy-back line on an alaris primary set.Ten min after the anesthesiologist had connected the on-q device, the rn realized the bupivacaine was being administered via the alaris iv set and not the sciatic nerve catheter as intended.Fortunately, the rn noticed this and reacted immediately, there was no harm to the pt.Attached are several images which show that this device has a female luer lock end that is compatible with any make luer lock ends such as an iv piggy-back site.This is very troubling given events that have been reported in the past related to inadvertent iv bupivacaine administration.(b)(6), access number: (b)(4).

• Brand Name: ON-Q PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL INC.; unk
• MDR Report Key: 8231825
• MDR Text Key: 132794376
• Report Number: MW5083010
• Device Sequence Number: 0
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1