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

Model Number US5062

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while emergently placing the patient on venoarterial extracorporeal membrane oxygenation (va ecmo) on (b)(6) 2022 there was color change upon initiation, but the amount of color change was questioned.Only a maximum flow of 2 liters per minute (lpm) was achievable.One unit of packed red blood cells (prbcs) and 750 milliliters of 5% albumin was given through the ecmo circuit.There was no change with volume transfusion, so pre and post-oxygenator pressure domes were added on subsequently.The pre-oxygenator pressure was measured at 370 mmhg with the post-oxygenator pressure measuring at 120 mmhg.The oxygenator was changed to the quadrox and all issues resolved.The flow returned to >4 lpm.

Event Description

Additional information was received that the color change between the venous inlet and arterial outlet was questioned which was used as an additional check to ensure oxygenator function.The pump speed was 3000 rotations per minute (rpm).The post oxygenator saturation was less than 250 millimeters of mercury (mmhg) at 100% fraction of inspired oxygen (fio2).

Manufacturer Narrative

Section a: patient information was requested but was not able to be provided manufacturer's investigation conclusion: a specific root cause for the report of an inability to increase the blood flow through the oxygenator to greater than 2 liters per minute (lpm) could not be conclusively determined through this evaluation.The reported event was unable to be recreated as the device was not returned for evaluation.The eurosets amg (advanced membrane gas exchange) pmp (polymethylpentene) oxygenator, lot # 7383208, will reportedly not be returned for evaluation as it was discarded.The production documentation for amg pmp oxygenator, lot number 7383208, was reviewed by the external manufacturer (eurosets) and showed that all tests made in the production process were compliant with the technical specifications.The eurosets amg pmp instructions for use (ifu), rev.04, is currently available.Under the list of warnings, the ifu warns that during the extracorporeal circulation (ecc) a backup oxygenator is necessary and also warns 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
• Manufacturer (Section G): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15325496
• MDR Text Key: 298951473
• Report Number: 3003752502-2022-00003
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 8034013782020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US5062
• Device Lot Number: 7383208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization