MAUDE Adverse Event Report: HALYARD / AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM; PUMP, INFUSION, ELASTOMERIC

Model Number CB0004

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/29/2019

Event Type  Injury  

Event Description

The on-q pump pain relief system was inadvertently connected to the pt's hickman catheter than the right chest on-q catheter.We believe this error was due in part to the ability to easily connect the two devices.The pt's pain control was initially provided via epidural catheter; however, following removal of the epidural catheter, the plan was to begin continuous pain relief via the on-q pain relief system.The on-q catheter was present but not visible to the nurse and had not been used up until this point.The nurse was unfamiliar with on-q pumps and assumed the on-q pain relief system should be connected to the hickman catheter.The pt received ropivacaine via the hickman times four hours before the error was identified and corrected.There was no adverse outcome as a result of this event.Our concern was the ability to easily connect the two devices.Fda safety report id# (b)(4).

• Brand Name: ON-Q PAIN RELIEF SYSTEM
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD / AVANOS MEDICAL, INC. ; alpharetta GA 30004
• MDR Report Key: 8879298
• MDR Text Key: 153983999
• Report Number: MW5088912
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: CB0004
• Device Catalogue Number: 101347203
• Device Lot Number: 0002968472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2019
• 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: 63 YR
• Patient Weight: 24