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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Diaphoresis (2452)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 19-jun-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.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: unknown.Flow rate: 6ml/hr.Procedure: shoulder surgery/rotator cuff procedure.Date of surgery: (b)(6) 2020.Cathplace: unknown.It was reported the patient underwent rotator cuff repair and "experienced shortness of breath, went pale, had high blood pressure and heart rate of 107" beats per minute.The patient went to the emergency room (er) and was told she was experiencing an allergic reaction to the medication.The patient was discharged with clamped on-q pump.The on-q pump was not discontinued at the hospital.The patient's spouse called for guidance on the removing catheter.The catheter was removed by the family member via telephone instructions and guidance.The patient had the catheter in for less than 24-hours and during "some of those hours were with the catheter clamped.".

• 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: 10175318
• MDR Text Key: 199069261
• Report Number: 2026095-2020-00106
• Device Sequence Number: 1
• Product Code: MEB
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2020

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 Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 66