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

Model Number US5062

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Dyspnea (1816); Hypoxia (1918); Thrombus (2101); Anxiety (2328); Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)

Event Date 10/04/2020

Event Type  Injury  

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 having decreasing oxygenation with patient arterial blood gas, post oxygenator arterial blood gas had decreasing pa02s.Their hemodynamics are stable, pressure gradient is stable and no signs of clot in the oxygenator.The patient is tachypneic with increased anxiety, and increasing shortness of breath.The patient was sedated and the oxygenator was changed out.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of suspected thrombus and insufficient gas exchange could not be confirmed as the device is not available for investigation.A specific cause for the reported event could not conclusively be established through this evaluation.Thrombus was not confirmed.The eurosets amg pmp oxygenator, lot number unknown, was disposed of by the account and the patient was reportedly stable.The external manufacturer confirmed that all tests from the production process were compliant with the technical specifications and confirmed that they apply the 100% production process test to all devices.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 list of precautions, the ifu cautions that a strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures.The benefit of extracorporeal support must be weighed against the risk of systemic anticoagulation and must be assessed by the prescribing physician.Adequate heparinization must be maintained before and during bypass.The "priming and recirculation procedure" section warns to check the correct dosage of anticoagulant in the system before starting the bypass.The "bypass start" section states to check that anticoagulation level (act) is appropriate before starting the procedure.This section also contains a subsection on blood gas monitoring and explains how to adjust the relevant parameters based on the patient¿s blood gas values.The "during bypass" warns that the act (activated coagulation time) must always be longer than or equal to 480 seconds in order to ensure adequate anticoagulation of the extracorporeal circuit.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: 10741900
• MDR Text Key: 213259653
• Report Number: 3003752502-2020-04151
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 89