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 Problems High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Shaking/Tremors (2515); No Code Available (3191)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18-sep-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: unknown.Flow rate: 2ml/hr.Procedure: labral tear of the shoulder.Cathplace: unknown.Date of surgery: (b)(6) 2020.It was reported the patient presented to the emergency room (er) with tremors, muscle contractions and rhythmic spikes in blood pressure.The patient was shivering and able to answer questions but not super alert.The pharmacist advised to clamp the pump off and see how the patient does in 4-hours and follow-up with the anesthesiologist to see what medication was in the pump.An ekg was performed and the pump was clamped.After the pump was clamped for 4-hours the pharmacist said the "patient did a complete 180 and was totally fine." the patient was more alert and his blood pressure leveled out.The patient did not have shivers or muscle contractions anymore.The pump was removed and given to the patient to take home.It was noted the pump was still very full with medication upon removal per the pharmacist.The patient was sent home and stable.The anesthesiologist stated the patient, "had a hard time coming out of anesthesia and was very agitated.".

Event Description

Flow rate: 10ml/hr.

Manufacturer Narrative

All information reasonably known as of 15-oct-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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

Manufacturer Narrative

The device history record for the reported lot number, 30025870, 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 08-dec-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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• 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
• MDR Report Key: 10556445
• MDR Text Key: 215902462
• Report Number: 2026095-2020-00119
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2020

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 Expiration Date: 07/09/2022
• Device Model Number: CB004
• Device Catalogue Number: N/A
• Device Lot Number: 30025870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 11/10/2020
• Supplement Dates FDA Received: 10/16/2020; 12/08/2020
• Patient Sequence Number: 1
• Treatment: ROPIVICAINE 0.2%
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 82