MAUDE Adverse Event Report: AVANOS MEDICAL, INC. 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 Problem No Code Available (3191)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Patient code: metallic taste in his mouth, lightheadedness, head pressure, feeling off when standing-up, and loss of appetite.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 10-aug-2020 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: 550 ml.Flow rate: 8 ml/hr.Procedure: bicep tendinosis repair.Cathplace: unknown.Date of procedure: (b)(6) 2020.It was reported on (b)(6) 2020, "a patient who has a bicep tendinosis repair done on (b)(6) 2020 reported a gradual onset of metallic taste in his mouth, lightheadedness, head pressure, feeling off when he stood up, and loss of appetite.(b)(6) 2020, the third day with the pump running at 8 ml/hr (patient did not adjust the rate, although he did have a saf)." the patient felt the worst he had over the course of the 3-days on (b)(6) 2020.The patient had already clamped off the pump when he called me.The patient was advised to contact the on-call anesthesiologist right away and report his symptoms.The patient was unable to reach the physician.The physician told the patient to remove the catheter on the 3rd day.Eventually, the patient had reached the physician who advised him to discontinue the pump, drink water, and monitor the symptoms and call back if it had gotten worse."patient reported feeling more clear headed ever since the pump was clamped off.".

• 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, INC.; 5405 windward parkway; alpharetta GA 30004
• 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: 10402505
• MDR Text Key: 235019672
• Report Number: 2026095-2020-00110
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494134723
• UDI-Public: 00193494134723
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2020

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: Lay User/Patient
• Device Model Number: CB004
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/13/2020
• 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