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 09/06/2023

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 the neonatal oxygenator was in use in an extracorporeal membrane oxygenation (ecmo) circuit, it started to leak blood at the bottom of the oxygenator.Blood was collecting below the venous blood inlet.The oxygenator was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the returned oxygenator confirmed evidence of the reported leakage; however, the issue could not be reproduced during functional testing by eurosets.A specific root cause for the reported event could not be conclusively determined through this evaluation.The eurosets standalone polymethylpentene (pmp) neonatal oxygenator, serial number: (b)(6), was returned to the abbott where an initial visual inspection was performed.Tubing segments were observed attached to the blood inlet and blood outlet ports, and the purge line was connected to its port.Visual inspection of the oxygenator revealed no obvious damage to the external housing, ports, or fibers.Of note, the entire oxygenator was covered with mold.Blood residue was observed inside the bottom housing near the blood inlet port which appeared to suggest that leaking had occurred in this area.The top housing revealed blood on its exterior, but the interior appeared dry.The oxygenator was forwarded to the external manufacturer, eurosets, for technical analysis.The oxygenator was set up in a circuit with a 500-milliliter reservoir of physiological water and a peristaltic pump.The oxygenator was filled with physiological water via the peristaltic pump, and the water was circulated through the oxygenator at a flow of 6 liters per minute (lpm) for 3 hours.No leaks were observed during this time.Eurosets reviewed the production documentation for the oxygenator lot and confirmed that 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.The eurosets advance gas membrane (amg) pmp infant oxygenator instructions for use (ifu) warns that the extracorporeal circulation always has to be carefully and continuously checked.This document additionally states that a spare oxygenator must always be available during perfusion.If particular situations occur which may lead the person responsible for perfusion to determine that the safety of the patient may be compromised (including leaks), oxygenator replacement should be performed per the ifu guidelines.The production documentation for standalone pmp neonatal oxygenator, serial number: (b)(6), 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 gas membrane (amg) pmp infant oxygenator 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.

Event Description

There were no issues noted while priming the oxygenator prior to the support, and that the event occurred 9 hours and 19 minutes after initiation of support.At the time of the event, the patient's partial thromboplastin time (ptt) was 63 and the oxygenator pressure at the inlet was 200 and the outlet it was 171.There was no adverse impact to the patient and they were decannulated on (b)(6) 2023 and discharged from the hospital.The cause of the leak was not identified.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 17825893
• MDR Text Key: 324372634
• Report Number: 3003752502-2023-02397
• 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: 03/12/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• 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