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

Model Number	US5088
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 - additional device information.Sn updated.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that upon opening the oxygenator, the customer discovered the arterial outflow connection was damaged.
Additional Manufacturer Narrative
D4: udi - corrected.D9 - corrected.Manufacturer's investigation conclusion: evaluation of the oxygenator confirmed the reported event; however, a specific root cause was unable to be conclusively determined.The eurosets standalone pmp (polymethylpentene) neonatal oxygenator, lot number 10246000, was returned and an initial visual inspection was performed at abbott.Visual inspection of the oxygenator revealed damage to the blood outlet port, with its edge appearing dented.The oxygenator was forwarded to the manufacturer (eurosets) for technical analysis, and eurosets confirmed that the arterial outlet was deformed.Eurosets determined that the device was damaged after the eurosets manufacturing process, and therefore, the real root cause of the problem was unable to be determined.Eurosets communicated that this event will be monitored, and in case of adverse trends, further investigation and/or corrective actions will be carried out.The production documentation for eurosets standalone pmp (polymethylpentene) neonatal oxygenator, lot number 10246000, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.The eurosets advanced membrane gas exchange (amg) pmp infant oxygenator instructions for use (ifu), rev.00, 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 extracorporeal circulation has to be carefully and continuously checked by qualified healthcare professionals throughout the procedure.Under the "set up" section, the ifu warns the user to "carefully inspect the device before use.Do not use it if the package is wet, opened or damaged, if the device is visibly damaged or if the protective caps are not in place" and 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." 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: 20907507
• Report Number: 2916596-2024-52497
• Device Sequence Number: 4008566
• Product Code: DTZ
• UDI-Device Identifier: 08052705493368
• UDI-Public: (01)08052705493368(10)010246000(17)270502
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: US5088
• Device Catalogue Number: US5088
• Device Lot Number: 010246000
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/02/2025; 05/22/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/16/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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
• Patient Sex: Unknown