MAUDE Adverse Event Report: MC3 INC. NAUTILUS; ECMO OXYGENATOR

Model Number	48145
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mc3 investigated the returned product.That had clotted off and required device exchange.The root cause of low flow performance ot the oxygenator and device change-out is believed to be a blood clot in the fiber bundle created by an upstream circuit source, possibly the pumphead or patient based on the following: customer stated there was an abrupt drop in flow at approximately 6am, 4.5 hours after the start of procedure.According to records, the device performed as expected for 4.5 hours which describes normal function.No observation of clots in circuit prior to 6am.Oxygenator adjustments would have been made if there was an obstruction preventing flow, prior to 6am.The abrupt drop in flow indicates the clot suddenly entered the fiber bundle, inhibiting flow and causing change-out.Customer described that the pumphead " felt hot" which has an unknown impact.The pump was not retained so could not be investigated.An impella device was also used in this patient with unknown impact.This is believed to be an isolated incident with no impact to production or product in the field.
Event or Problem Description
Distributor received information that during use of a mc3 nautilus oxygenator, there was difficulty maintaining flow above 0.5 l/min.The system/pump/circuit was changed out for cardiohelp.And the flow improved to 3.5-4.0 l/min.It was suspected that the nautilus clotted off.The ap40 centrifugal pump was part of the circuit.Additional information from the sales rep: the patient was on fem -fem va extracorporeal membrane oxygenation (ecmo).The patient had been placed on support on (b)(6) 2020 at 01:29.Rpm: 3070, flow: 4.3l/min new flow with cardiohelp: 4.0l/min, 3665rpm.Cardiac patient placed on fem-fem va ecmo and impella for support.Drainage lt fem ven: 24fr edwards reinfusion lt fem art: 18fr edwards loading dose of heparin was 5,000, no heparin after.Pt: 22, inr: 2.1, aptt: 90.2.An adapter was not used with the ap40, it was mounted directly in the bio-console.

• Brand Name: NAUTILUS
• Common Device Name: ECMO OXYGENATOR
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• MDR Report Key: 10525491
• Report Number: 3011468686-2020-00005
• Device Sequence Number: 14465981
• Product Code: BYS
• UDI-Device Identifier: 10854916006888
• UDI-Public: 10854916006888
• Combination Product (Y/N): N
• PMA/510(K) Number: K191935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Type of Report: Initial
• Report Date (Section B): 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 48145
• Device Catalogue Number: 48145
• Device Lot Number: 2005164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR