MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW AND NRFIT CONNECTOR; ELASTOMERIC - SAF

Model Number CB004-N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 03/10/2020

Event Type  Death  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record determined the lot number reported was not a valid avanos lot number.Root cause could not be determined.All information reasonably known as of (b)(6) 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: 545 ml.Flow rate: 6ml/hr.Procedure: bilateral knee surgery.Cathplace: unknown.Avanos medical received a single report that referenced 2 separate units, involving one event.This is the second of two reports.Refer to 2026095-2020-00115 for the first event.It was reported the patient passed away on (b)(6) 2020 after a bilateral knee procedure.The patient was at home with no signs or symptoms of toxicity.Additional information received 21-aug-2020 stated it was reported via the coroner¿s office, coroner¿s report noted after reviewing medical and social history, assessment at the scene, interviews with family and autopsy/toxicology results the cause of death is ropivacaine toxicity.Manner of death was accident.Additionally, per the coroner's report the date of death was (b)(6) 2020.Additional information received 26-aug-2020 stated the pump was filled with 2.0mg/ml ropivacaine in 0.9% normal saline(ns).

Manufacturer Narrative

The device history record for the reported lot number: 0002998236, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The actual sample was not returned for further evaluation of the potential defect.Additionally, the sample was not available for evaluation at the failure analysis lab; however a sample review was conducted by an avanos representative at an external lab.The review was only visual not functional.The visual evaluation noted the clamp was open.The pump appeared to fluid remains.A binder clip was in place to crimp the tubing which created rust in the returned sample bag and on the product.The select-a-flow (saf) was set at 6 ml/hr.Root cause could not be determined.All information reasonably known as of 25-aug-2021 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

All information reasonably known as of 30-jul-2021 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.

Event Description

Additional information received 07-jul-2021 stated the patient was discharged home on (b)(6) 2020 with on-q pain pumps connected to each of her knees.On (b)(6) 2020, the patient was found deceased in her home.".

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 19-nov-2021 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 was evaluated and no fast flow was observed.Additionally, the device did not exhibit obvious occlusion in microtubing during pressure pot testing.Root cause could not be determined.All information reasonably known as of (b)(6) 2022 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 21 cfr 803, 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 AND NRFIT CONNECTOR
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10532100
• MDR Text Key: 206865875
• Report Number: 2026095-2020-00117
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/24/2022

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 Expiration Date: 02/05/2022
• Device Model Number: CB004-N
• Device Catalogue Number: N/A
• Device Lot Number: 0002998236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 07/07/2021; 07/29/2021; 11/02/2021; 02/23/2022
• Supplement Dates FDA Received: 08/02/2021; 08/25/2021; 11/22/2021; 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: ROPIVACAINE IN 0.9% NS.; ROPIVACAINE IN 0.9% NS.
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 106 KG