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

Model Number US5062

Device Problem Mechanical Problem (1384)

Patient Problems Abnormal Blood Gases (1034); Low Oxygen Saturation (2477)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

User facility report: (b)(4) was received on 15sep2020.On 04jul2020, it was reported the patient was on the first oxygenator that was exchanged but had normal performance and no allegation against the device (reported in mfr report #2916596-2020-03683).On 15sep2020, additional information was received in a user facility report that there was an allegation against the first oxygenator because the post membrane partial pressure of oxygen (pao2) had continually trended downward.On 09oct2020, information from the site was received that this event in the user facility report was related to the event in mfr report #2916596-2020-03683.The exchanges were for the same patient on the same day but two different oxygenator devices.This report is to report on the first oxygenator exchange.The patient¿s second exchange was reported in mfr report #2916596-2020-03683.

Event Description

The site communicated that the patient was a covid positive patient, had been on centrimag/oxygenator for nine days with normal performance.Team changed out oxygenator to new oxygenator.Within 30 minutes of oxygenator exchange, post gas showed partial pressure of oxygen (pao2) of 235 mmhg then an hour after, 92.8 mmhg.The site changed it out again and the new oxygenator was performing correctly.It was later reported in a user facility report for this event that the post membrane pao2 continually trended downward which was why the first oxygenator was exchanged.The exchange was done at the patient's bedside with sterile technique.The patient remained stable with each equipment change.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of insufficient gas exchange could not be confirmed as the device is not available for investigation.It was reported that the patient had been on centrimag/oxygenator support for 9 days following a covid diagnosis with normal performance.However, the patient¿s doctor noted that post-membrane partial pressure of oxygen (pao2) had been continually trending downward and an initial oxygenator exchange was performed.The patient remained stable during each equipment exchange with no adverse patient consequences noted.The patient continued in the intensive care unit (icu) on extracorporeal membrane oxygenation (ecmo) support.It was reported that due to the patient¿s covid 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: 10687066
• MDR Text Key: 211855486
• Report Number: 3003752502-2020-04153
• 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,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 146