MAUDE Adverse Event Report: HALYARD HEALTH ON-Q PUMP; PUMP, INFUSION, ELASTOMERIC

Catalog Number CB006

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Toxicity (2333)

Event Date 02/28/2017

Event Type  Injury  

Event Description

On-q on demand pain pump delivered more than the ordered and set delivery rate resulting in anesthetic toxicity.Volume in the pump was delivered over 1 day vs intended 4 day.Patient had a prolonged hospitalization due to event but has recovered and is doing well.

• Brand Name: ON-Q PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6493196
• MDR Text Key: 72806188
• Report Number: 6493196
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CB006
• Device Lot Number: 202542787
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2017
• Event Location: Other
• Date Report to Manufacturer: 03/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR