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

Model Number US5062

Device Problem Noise, Audible (3273)

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

Event Date 10/23/2021

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 priming an extracorporeal membrane oxygenation (ecmo) circuit with a eurosets oxygenator, the oxygenator made a high pitch squealing noise while flowing at 2400 rpm.The higher the rpm, the higher the pitch and louder the noise.The oxygenator was removed from the circuit, and was replaced with another eurosets oxygenator.The noise resolved after the exchange.The oxygenator was never used on a patient.

Manufacturer Narrative

Manufacturer's investigation conclusion: eurosets confirmed an audible flowing noise upon performing a pressure drop test to the returned eurosets amg (advanced membrane gas exchange) pmp (polymethylpentene) oxygenator.A specific root cause for the noise could not be conclusively determined through this evaluation.The eurosets oxygenator, lot # 7081108, was returned to abbott and an initial visual inspection was performed.Visual inspection of the oxygenator revealed that the oxygenator had segments of tubing connected to the blood inlet and outlet ports that were clamped and the oxygenator was filled with a priming solution.No obvious damage or other abnormalities were identified.The oxygenator was forwarded to the external manufacturer (eurosets) for technical analysis.The oxygenator was set up and a pressure drop test was performed with flow noising clearly audible.Eurosets reviewed the production documentation for the oxygenator lot and confirmed all tests from the production process were compliant with the technical specifications.Eurosets confirmed that they apply 100% production process tests to all of their devices.Eurosets is still investigating on the root cause of this kind of issue.The eurosets amg pmp instructions for use (ifu) 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.Also, under the list of warnings, the ifu warns that ¿before using the product it is advisable to carefully inspect it.Shipping and handling could cause structural and functional damage to the device.¿ the section entitled ¿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: 12851874
• MDR Text Key: 287681323
• Report Number: 3003752502-2021-00012
• 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
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• 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: 7081108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2022
• 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