MAUDE Adverse Event Report: AVANOS MEDICAL ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number CB6004

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

Patient Problem Death (1802)

Event Date 09/28/2018

Event Type  Death  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 0202983490, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Root cause could not be determined.All information reasonably known as of 17-oct-2018 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).

Event Description

Fill volume: 750 ml.Flow rate: 14 ml/hr.Procedure: rib fractures.Cathplace: subpleural nerve block.It was reported that a patient died associated with the use of an elastomeric pump.The patient was an (b)(6) female patient that had nine rib fractures after being involved in a car accident.Surgery was performed on the patient on (b)(6) 2018.A catheter was placed on the subpleural nerve block for use with an on-q pump following the surgery.The patient was reported to be doing well post-op.On (b)(6) 2018 it was noted that the patient's oxygen level desaturated rapidly and went into pea (pulseless electrical activity).The patient died with an unknown cause of death.No drug level in the blood was assessed and no autopsy was performed.

Manufacturer Narrative

All information reasonably known as of 09-nov-2018 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).

Event Description

Additional information received on 19-oct-2019 stated that nurse who was present did not think that the patient had typical local anesthetic toxicity from the on-q pump.The patient was decompensated about one hour before she stopped breathing.The patient exhibited stroke-like symptoms, weakness in the arm on the left side of the body.The computed tomography scan was clear and did not show any ischemic stroke.The patient stopped breathing quickly, her chest tube came out, and she was also bleeding.The actual cause of death was not shared by the hospital.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL; 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta 30004 ; 4704485444
• MDR Report Key: 7986304
• MDR Text Key: 124462142
• Report Number: 2026095-2018-00111
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• 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,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

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: 10/24/2020
• Device Model Number: CB6004
• Device Catalogue Number: 101347603
• Device Lot Number: 0202983490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR