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 11/01/2023

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 the oxygenator was leaking around the plastic shell.The leak occurred during priming.The oxygenator was not used on a patient and removed from service.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the returned oxygenator could not confirm the reported event.The eurosets standalone polymethylpentene (pmp) neonatal oxygenator, lot number 9351300, was returned to the abbott facility in burlington, ma, where an initial visual inspection was performed.All ports were returned covered by their respective protective caps, 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.The oxygenator was forwarded to the external manufacturer, eurosets, for technical analysis, where it 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 6 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 production documentation for standalone pmp neonatal oxygenator, lot number 9351300, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.The eurosets 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.The ifu also warns to not use the product if, during priming or operation, a visual inspection detects the presence of air microbubbles/bubbles in the oxygenator.Undetected bubbles or too low a liquid level in the reservoir can cause air embolism in the patient.These can cause gaseous emboli to the patient.Under the section titled, ¿priming and recirculation procedure¿, the ifu contains instructions on how to purge the air from the oxygenator and circuit.This section warns the user to remove all the air microbubbles/bubbles before starting the extracorporeal circulation.Air entrainment or oxygenator incorrect de-airing may cause air emboli to the patient and consequent serious injury or death.This section also warns the pressure level inside the blood compartment must not exceed 750 mmhg.The ifu also recommends the use of a bubble trap or filter on the arterial line to reduce the risk of emboli transmission to the patient.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: 18273551
• MDR Text Key: 329826329
• Report Number: 3003752502-2023-02407
• Device Sequence Number: 1
• Product Code: DTZ
• 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: Physician
• Type of Report: Initial
• Report Date: 12/06/2023

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: US5088
• Device Lot Number: 009351300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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