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 Problems Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  Injury  

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 the patient was placed on extracorpeal membrane oxygenation (ecmo) in the catheterization lab.Upon initiation of support, the pre-oxygenation pressures of the eurosets oxygenator exceeded 350 mmhg.Despite this, flow was unable to surpass 3.5 liters per minute, no matter how high the centrimag¿s rotations per minute were increased.Pressure alarms sounded and were also displayed.The eurosets oxygenator was exchanged and support to the patient was resumed.

Event Description

The issue with the oxygenator occurred immediately after initiation of support.The patient had been minimally hypoxic prior to initiating extracorporeal life support (ecls) with a different cannulation strategy on the new circuit/ euroset.The patient was in a hypoxic state despite the fio2 on the vent being increased to 100%.The hypoxemia became worse on the new circuit/ euroset until the euroset was changed out.The oxygenator was exchanged for another eurosets oxygenator.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the flow issue could not conclusively be determined through this evaluation.The eurosets amg (advanced membrane gas exchange) pmp (polymethylpentene) oxygenator, lot number 7081108, was returned to the abbott facility in (b)(6), ma, where a visual inspection was performed.Segments of tubing were secured to the blood inlet and blood outlet ports with zip ties and pigtails were secured to both the blood inlet and outlet ports.A segment of screen tubing was connected to the gas inlet port.Visual inspection of the oxygenator revealed no obvious damage to the external housing, ports, or fibers.No blood was observed within the top or bottom orange housing.The production documentation for amg pmp oxygenator, lot # 7081108, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.The specific root cause of the reported issue could not be conclusively determined.The eurosets amg pmp instructions for use (ifu) is currently available.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.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 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
• 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: 12623699
• MDR Text Key: 282120327
• Report Number: 3003752502-2021-00011
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 08034013782020
• 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,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 7081108F0265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 11/05/2021; 02/26/2022
• Supplement Dates FDA Received: 12/02/2021; 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White