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

Model Number US5088

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

It was reported that the pediatric oxygenator had blood coming out of the gas exhaust port and pooling on the ground about 24 hours after priming and 6 hours after blood priming.The circuit was exchanged to a new one with the same disposables.The blood loss was not noted to be more than 50ml.It was suspected to be a fiber leak.There were no patient consequences.The patient was continuing to recover and was supported with venoarterial extracorporeal membrane oxygenation (va ecmo).The flow of the pump at the time of the leak was 0.27 lpm, the rate of the gas flowing to the system at the time of the leak was 0.15 lpm.The inlet pressure was 112 mmhg.The pump motor speed was 2900 rpm.The partial thromboplastin time was greater than 200 seconds.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: eurosets confirmed a blood leak of the returned eurosets amg (advanced membrane gas exchange) pmp (polymethylpentene) oxygenator.A specific root cause for the leak could not be conclusively determined; however, fiber breakage was suspected.The eurosets amg standalone pmp infant oxygenator, lot # 8120500, was returned to abbott and an initial visual inspection was performed that confirmed blood residue in the gas inlet port and bottom and top housings.Visual inspection of the pmp fibers from the side of the oxygenator revealed no obvious damage and was unable to confirm fiber breakages.There were no other findings noted.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 peristaltic pump.The water was circulated through the oxygenator for 10 minutes at a flow of 6 liters per minute.During this time, no leaking of any kind was observed to come from the oxygenator, most probably due the condition of the device at its arrival.Despite that, there were some traces of blood in the lower lid of the oxygenator and for this reason it was removed.The point of loss was not detectable, but the presence of blood can suggest a blood leakage due a broken fiber.The device history record for amg standalone pmp infant oxygenator, lot # 8120500, was reviewed by eurosets 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).The specific root cause of the reported issue could not be conclusively determined; however, eurosets determined that the issue occurred after eurosets manufacturing and test phases.Eurosets reported that after thoughtful and deep investigation on possible improvement processes, a series of additional, specific controls and manufacturing changes have been implemented which have been able to reduce the occurrence of this issue.The eurosets amg pmp instructions for use (ifu) warns that that during extracorporeal circulation (ecc) a backup oxygenator is necessary and also warns that the extracorporeal circulation has to be carefully and continuously checked.Before using the product, it is advisable to fully inspect it as shipping and handling could cause structural and functional damage to the device.The ifu also states that 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.The production documentation for amg standalone pmp infant oxygenator, lot # 8120500, was reviewed by the external manufacturer (eurosets) and showed that all tests made in 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.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.¿ 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: STANDALONE PMP NEONATAL OXYGENATOR
• 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: 17353488
• MDR Text Key: 320031477
• Report Number: 3003752502-2023-02391
• 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: K202510
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US5088
• Device Catalogue Number: US5062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Weight: 2 KG