MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number CB004

Device Problem Infusion or Flow Problem (2964)

Patient Problems Fever (1858); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); No Code Available (3191)

Event Date 03/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for the reported lot number, 0203116060, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 16-apr-2019 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, inc.Complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 500 ml, flow rate: 12 ml/hr, procedure: c-section, cathplace: unknown.It was reported the patient called at 2:30pm from the hospital because the pump was empty.The patient was instructed by the nurse that an order from the doctor was required to remove to the pump.The nurse instructed the patient to call the nurse hotline because she did not deal with pain pumps often.Again, the hospital nurse instructed the patient that the pump should not be removed unless there was a physician's order.The nurse hotline instructed the patient to have the hospital nurse call the nurse hotline for any questions.The hospital nurse called the nurse hotline at 1:30am because the patient had a reaction from the pump, which included an increased temperature, elevated blood pressure and elevated pulse.Redness was noted near the catheter insertion.The patient did not complain of ringing in the ears nor metal taste in her mouth.The physician removed the pump about 20-minutes before the call to the nurse hotline and the patient's vital signs were stabilizing.A computed tomography (ct) scan was ordered.The hospital nurse said she was too busy at that time to give any further information and would call back later.The hospital nurse called back at 6:15am.The hospital nurse stated the doctor wrote that he feels medication has settled in the patient's subfascial tissue.A new pump was hung at 2:30pm and the patient was instructed she could increase the flow rate at 2ml increments.The patient increased the flow rate to 12ml/hr.The hospital nurse stated that after a discussion the patient noted she did have a metal taste in her mouth, which had resolved but the patient denied ringing in the ears.The patients vital signs were stable.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 8523747
• MDR Text Key: 142277689
• Report Number: 2026095-2019-00059
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/24/2019

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: Lay User/Patient
• Device Expiration Date: 04/26/2021
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 0203116060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2019
• Initial Date FDA Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ROPIVICAINE 0.2%
• Patient Age: 22 YR
• Patient Weight: 75