MAUDE Adverse Event Report: EUROSETS S.R.L. STANDALONE PMP NEONATAL OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	US5088
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the oxygenator failed and was exchanged.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was additionally reported that there was patient desaturation starting at the time of the component change.This occurred after approximately 20 hours of support.It was noted to have red colored fluid from the gas exhaust port of the oxygenator, increasing with sigh of lung.The parameters at the time were 0.28 lpm at 2600 rpm blood flow.The sweep was 0.5 lpm at 1.0 fio2.The venous pressure 3/ arterial pressure 81.The gas analysis was patient arterial 7.36/39.7/54, pump venous 7.4/33.7/111 and pump arterial 7.47/28.7/379.
Additional Manufacturer Narrative
Section d1: correction.Section d1 (model number, catalog number, primary unique device identification (udi) number): correction.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned oxygenator by the manufacturer (eurosets) confirmed an oxygenator leak due to fiber breakage; however, a specific root cause for the fiber breakage could not be conclusively determined through this evaluation.It was reported that the oxygenator failed after approximately 30 hours and was exchanged.The reported failure was described as a red-colored fluid from the oxygenator¿s gas exhaust port that increased with sigh of lung.The blood flow rate was 0.28 liters per minute (lpm) with pump speed of 2600 revolutions per minute.Sweep gas was at 0.5 lpm and 1.0 fraction of inspired oxygen.Venous pressure was reported as 3 while arterial pressure was 81.The gas analysis values were provided as follows: patient arterial 7.36/39.7/54, pump venous 7.4/33.7/111, and pump arterial 7.47/28.7/379.It was reported that the patient experienced desaturation at the time of component change.The oxygenator was returned to abbott where an initial visual inspection was performed that revealed no obvious damage.It was noted that blood residue was found within the bottom housing of the oxygenator.The blood residue was within the gas pathway, which was consistent with the reported leak.The oxygenator was forwarded to the external manufacturer (eurosets) for technical analysis.The oxygenator was placed on a mock loop with physiological water.The oxygenator was filled using a peristaltic pump at 6 liters per minute (lpm) and remained in the mock loop for 2 hours.During this time, no leak was observed.The device was sectioned by removing the lower housing to check for the presence of blood.The leakage was determined to be due to a broken fiber; however, the exact point of loss was unable to be identified due to clotted blood within the device.The device history record for the eurosets infant oxygenator, lot number 9587500, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.Devices are required to pass manufacturing inspections and specifications prior to release, and no abnormalities were documented which would cause or contribute to the reported occurrence.This device passed all required testing.Eurosets confirmed that 100% of the oxygenators produced are tested to detect eventual leakages using a pressure of 150 kpa (kilopascals) which is 1.5 times the maximum blood pathway pressure indicated on the ifu (instructions for use).Devices that exhibit leaks are discarded prior to distribution.Eurosets determined that the issue occurred after eurosets¿ manufacturing and test phases.Eurosets communicated that their production process and controls will continue to be improved to further reduce the occurrence rate of these events, which will also be monitored for adverse trends.Additional investigation of oxygenator leaking issues has been initiated by abbott and sent to eurosets (oxygenator supplier/manufacturer) through a supplier corrective action request.Actions have been taken to prevent reoccurrence.The production documentation for the eurosets infant oxygenator, lot number 9587500, 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 infant cardiopulmonary bypass oxygenator instructions for use (ifu), document eu10735, rev.00, is currently available.Under ¿risks and side effects,¿ the ifu lists possible risks and side effects, including blood leakage (caused by mechanical failure) and insufficient gas exchange: insufficient oxygenation of blood (hypoxia, hypoxemia, brain injury, metabolic acidosis) or insufficient co2 removal (respiratory acidosis, hypercapnia).These are potential side effects of all extracorporeal blood circulation systems.The ifu includes warnings: -that the device is intended to be used by professionally trained personnel.-that the extracorporeal circulation has to be carefully and continuously checked by qualified healthcare professionals throughout the procedure.-to carefully check the device seal during priming and operation.If you notice leakage during priming or operation, replace the defective device following good perfusion practices.-that during use, a spare a.M.G.Pmp infant oxygenator must always be available.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.This section also instructs to check that all connections are properly secured.Under the section titled ¿during bypass¿, the ifu instructs that during the entire procedure, according to good prefusion practices, monitor the integrity of the system for leaks absence.The section titled ¿oxygenator replacement¿ includes instructions for oxygenator replacement.This section instructs 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 that the safety of the patient may be compromised, (insufficient oxygenator performance, leaks, abnormal blood parameters etc.), proceed as follows for oxygenator replacement.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: STANDALONE PMP NEONATAL OXYGENATOR
• Common Device Name: 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21816379
• Report Number: 3003752502-2025-00016
• Device Sequence Number: 7288048
• Product Code: DTZ
• UDI-Device Identifier: 08052705493368
• UDI-Public: (01)08052705493368(10)09587500(17)261016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: US5088
• Device Catalogue Number: US5088
• Device Lot Number: 09587500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 04/18/2025; 06/16/2025; 12/08/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/09/2025; 06/30/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 3 KG