MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q ELASTOMERIC PUMP, 270 ML X 5 ML/HR; ELASTOMERIC LFR

Model Number	P270X5
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Unspecified Mental, Emotional or Behavioural Problem (4430)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 23 feb 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: 270 ml.Flow rate: 5ml/hr.Procedure: rib fracture.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the pump emptied sooner than expected.The patient was being treated for rib fractures and also had a reaction to the local anesthetic.Per additional information received 5 feb 2021, a single catheter had been placed, and the pump appeared to be empty at around 36 hours.The patient reported feeling sick around 24 hours post operative.The doctor stated that she feels the patient experienced bupivacaine toxicity.Per additional information received 22 feb 2021, the patient's current status is stable.The patient reported that they experienced "mental status change" as a result of the bupivacaine toxicity.The medication provided in the pump was 0.5% bupivacaine.The patient was given a lipid emulsion for treatment.The pump was expected to last two and a half to three days, and the pump had emptied less than 48 hours after surgery.

• Brand Name: ON-Q ELASTOMERIC PUMP, 270 ML X 5 ML/HR
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11373754
• Report Number: 2026095-2021-00039
• Device Sequence Number: 11435142
• Product Code: MEB
• UDI-Device Identifier: 00193494136734
• UDI-Public: 00193494136734
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P270X5
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 105