MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number US5062

Device Problem Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient was a covid positive patient initiated on ecmo support.The amg pmp found to have post membrane pao2 of 300, and the patient was not tolerating.The amg pmp oxygenator was taken out of the circuit and replaced with another manufacturer's device.The other oxygenator also failed to meet the patient's oxygen demand so it was cut out and replaced with another amg pmp.

Manufacturer Narrative

Section d4: correction.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of insufficient gas exchange, as well as a direct root cause for the event, could not be confirmed through this investigation.The external manufacturer (eurosets) concluded based on the internal investigation and reported information that no device malfunctions could be determined; the reported partial pressure of oxygen (pao2) values were within compliance with the product specifications.The adverse consequences to the patient included transient inadequate oxygen supply.It was reported that due to the patient¿s covid-19 diagnosis, the eurosets amg pmp oxygenator, lot number 5969906, would not be returned for evaluation.The production documentation for amg pmp oxygenator, lot number 5969906, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.The eurosets amg pmp instructions for use (ifu) is currently available.Under the section titled, ¿intended use¿, the ifu states that the ¿a.M.G.Module pmp no t.P.Sterile is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours¿ and also that the device ¿is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.Contact with blood for a longer period of time is unadvisable.¿ under the list of warnings, the ifu warns that during the extracorporeal circulation (ecc) a backup oxygenator is necessary and also wants that the extracorporeal circulation has to be carefully and continuously checked.Under the section titled, ¿bypass start¿, the ifu contains a subsection on blood gas monitoring and explains how to adjust the relevant parameters based on the patient¿s blood gas values.Under the section titled ¿oxygenator replacement¿, this document states that a spare oxygenator must always be available during perfusion.After 6 hours of use with blood or if particular situations occur, which may lead the person responsible for perfusion to determine the safety of the patient may be compromised (insufficient oxygenator performance, leaks, abnormal blood parameters, etc.), follow the procedure outlined in the ifu for oxygenator replacement.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• MDR Report Key: 10413168
• MDR Text Key: 203157918
• Report Number: 2916596-2020-04121
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K141492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: US5062
• Device Lot Number: 5969906
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 128