MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PUMP WITH SELECT-A-FLOW; ELASTOMERIC - SAF

Model Number CB004

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

Patient Problem Necrosis (1971)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 26 may 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

Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 2026095-2020-00066 for the first report.Fill volume: 400 ml, flow rate: unknown, procedure: total knee replacement, cathplace: knee, infusion start time: unknown, infusion stop time: unknown.It was reported that two "patients developed blisters around the knee, on the skin, of their leg which had a total knee replacement surgery.Both of these patients had one of their blisters become necrotic.The pumps were filled with 400ml 0.2% ropivacaine, plus four other drugs the surgeon was trialling as a mix.The other drugs: 1g tranexamic acid, 1:1000 adrenaline in 1ml ampule, 5.7mg celestone in 1ml ampule, 1ml ampule of ketorolac." additional information has been requested but not yet received.

Manufacturer Narrative

The device history record for lot 2968464 was reviewed and the product was produced according to product specifications.All information reasonably known as of 18 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.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 comp (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 27-may-2020 indicated the patient's infusion began (b)(6) 2020 1730 and ended (b)(6) 2020 1730.Blisters were noticed on (b)(6) 2020 and necrosis developed later, date unknown.The catheter was an epidural catheter, brand unknown.Total fill volume of the pump was 400ml and it was set to a flow rate of 8ml/hr.Patient received general anesthesia plus block.Catheter location was "medial femoral condyle, tip tucked posterior of the knee." surgeon noted the incident.Patient needed a "skin graft and plastic surgeon presence." the patient was ambulatory while using the pump.Patient's current condition was listed as "repair surgery has occurred." additional information received 02-jun-2020 indicated the pump was filled and primed according to the instructions for use.The surgeon wanted to trial adding the four drugs mentioned in the initial report [tranexamic acid, adrenaline, celestone, ketorolac ] to the local anesthetic in the pump to see if this improved the patient outcome.The hospital had two surgeons using the on-q pumps prior to this surgeon's trial.Staff was trained.Patient was a new user of the pump.The surgeon stated he "stitches [stitches] and closes the joint capsule tightly which would reduce the chance of leakage if the flow rate is too high.".

Manufacturer Narrative

Photos were provided and confirmed a reaction was observed in the customer's skin.Root cause could not be determined; however, based on the use review, the reaction observed can be a necrosis caused by the combination of drugs that the surgeon used as a trial.All information reasonably known as of 26 aug 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 PUMP WITH SELECT-A-FLOW
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 10089381
• MDR Text Key: 194464818
• Report Number: 2026095-2020-00067
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 10680651134728
• UDI-Public: 10680651134728
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

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 Expiration Date: 07/13/2021
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 2968464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 08/05/2020
• Supplement Dates FDA Received: 06/19/2020; 08/26/2020
• Patient Sequence Number: 1
• Treatment: 1:1000 ADRENALINE IN 1ML AMPULE; 1G TRANEXAMIC ACID; 1ML AMPULE OF KETOROLAC; 5.7MG CELESTONE IN 1ML AMPULE
• Patient Outcome(s): Other
• Patient Age: 59 YR