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 03/27/2021

Event Type  malfunction  

Event Description

It was reported that the patient was in the operating room for a lung transplant being supported with centrimag with amg pmp oxygenator.During the run, the perfusionist noted blood coming out of the water line ports at a slow, but consistent drip.To note, a heater/cooler was not utilized during this run.The oxygenator was not exchanged due to the patient coming off of support once the lung transplant operation was completed.The water lines were initially on but were taken off.The total time of the patient being supported on centrimag with amg pmp oxygenator was approximately 3 hours with leaking noted approximately 2 hours into the case.No alarms reported to the centrimag system.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the returned device confirmed a damaged fiber that would have caused the reported blood leak.The eurosets amg pmp oxygenator, lot number 6920908, was returned to abbott and an initial visual inspection was performed.Visual inspection of the oxygenator revealed dried blood within the orange housing of the device and dried blood within the gas outlet port, indicative of leakage.No obvious damage to the external housing, ports, or fibers was observed.The oxygenator was then forwarded to the external manufacturer (eurosets) for technical analysis.A test circuit was filled with physiological water and the oxygenator module was filled from the reservoir using a peristaltic pump.An initial flow of 6 lpm was established and the oxygenator remained in the loop for 10 minutes.At this time, a slow dripping was observed within the lower part of the oxygenator.In order to identify the exact point of leakage, the device was cut into sections by removing the gas-out lid, then re-filled with water and pressurized.The test revealed a point of loss that occurred due to a fiber breakage.A specific root cause for the damage to the fiber that caused the reported leaking could not be conclusively determined through the manufacturer's investigation.Production documentation was reviewed by the manufacturer and all tests from the production process were compliant with the technical specifications, suggesting that the damage occurred after production of the device.The production documentation for amg pmp oxygenator, lot number 6920908, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.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, ¿priming and recirculation procedure¿, the ifu provides instructions on how to prime the oxygenator for use including verifying the integrity of the heat exchanger and paying particular attention to possible water leaks.This section further warns that the ¿pressure level inside the blood compartment of the oxygenating module shall not exceed 100 kpa (1 bar / 14 psi)¿ and that the ¿blood side compartment pressure must be higher than the gas side compartment pressure¿.Additionally, this section states that the oxygenator should be primed by gravity.The ifu provides further instructions on how to open the arterial line, how to purge the air contained in the circuit, how to close the purging line, and how to close the venous and arterial lines in this section.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: 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
• MDR Report Key: 11717184
• MDR Text Key: 250411226
• Report Number: 3003752502-2021-00004
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K141492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

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 Expiration Date: 02/29/2024
• Device Model Number: US5062
• Device Lot Number: 6920908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 82