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

Model Number US5062

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

A1a-6: patient involvement is unknown at this time.A request for further information will be sent.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that a newly primed oxygenator had fluid leaking from the bottom.The oxygenator was removed from use.

Manufacturer Narrative

A1-a6: there was no patient involvement, therefore not applicable.Manufacturer's investigation conclusion: review of the submitted photos confirmed the reported oxygenator leak; however, a specific root cause for this finding could not be conclusively determined through this evaluation as the oxygenator was not returned for evaluation.It was reported that a newly primed circuit was found to have a leak from the oxygenator with fluid coming out of the bottom.The device was taken out of circulation for patient use.The submitted photos were reviewed and showed that the circuit/oxygenator appeared to be primed with clear fluid.A drop of clear fluid was noted near the inlet on the bottom blue section.The eurosets amg pmp oxygenator, lot # 7896808, was not returned for evaluation.The production documentation for the oxygenator were reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.Eurosets confirmed that oxygenators undergo multiple leakage tests during production, and devices that exhibit leaks are discarded prior to distribution.Devices are required to pass manufacturing inspections and specifications prior to release, and no abnormalities were documented in the device history record which would have caused or contributed to the reported occurrence.The device passed all required testing.Based only on the available information, the root cause of the reported event was unable to be determined by eurosets.The eurosets amg pmp instructions for use (ifu) warns that during extracorporeal circulation (ecc) a backup oxygenator is necessary and warns that the device must be carefully and continuously checked by qualified healthcare professionals.Before using the product, it is advisable to fully inspect it as transport and/or storage conditions other than those prescribed may have caused damage to the device.The production documentation for amg pmp oxygenator, lot number 7896808, 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) is currently available.Under the list of warnings, the ifu warns that during use, a spare oxygenator must always be available and also warns that the device has to be carefully and continuously checked by qualified healthcare professionals throughout the procedure.Also, under the section titled ¿set up¿, the ifu warns to ¿carry out a visual inspection and carefully check the device before use.Transport and/or storage conditions other than those prescribed may have caused damage to the device.¿ 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: 17585986
• MDR Text Key: 321561278
• Report Number: 3003752502-2023-02395
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US5062
• Device Lot Number: 7896808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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