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 05/24/2021

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 during priming of the amg adult pmp oxygenator the customer noticed a fluid leak form the fibers out of the bottom vented portion of the oxygenator.Set up was stopped and the oxygenated was replaced before it was used on a patient.

Manufacturer Narrative

Manufacturer's investigation conclusion: the production documentation for amg pmp oxygenator, lot number 6944908, was reviewed by the external manufacturer (eurosets) and showed that all tests made in 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.Eurosets confirmed a slow leak from the returned eurosets amg (advanced membrane gas exchange) pmp (polymethylpentene) oxygenator due to pmp fiber breakage.A specific root cause for the fiber breakage could not be conclusively determined through this evaluation.Review of the submitted video confirmed the report of a priming fluid leak from the fibers into the oxygenator housing at the bottom of the oxygenator, under the blood outlet port.The eurosets oxygenator was returned to abbott and an initial visual inspection was performed.Visual inspection of the oxygenator revealed some priming fluid within the bottom of the oxygenator housing; however, no obvious damage or other abnormalities were identified.The oxygenator was forwarded to the external manufacturer (eurosets) for technical analysis.The oxygenator was operated on a circuit with a reservoir of physiological water and peristaltic pump.A slow fluid dripping was noted in the lower part of the oxygenator.To identify the exact point of leakage, the device was sectioned by removing the gas-escape lid, refilled with water, and then pressurized.The point of loss occurred due to the fiber breakage of the last winding near the blood outlet port.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 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 in the ifu (instructions for use).The specific root cause of the fiber breakage could not be conclusively determined; however, eurosets determined that the fiber breakage would have occurred after eurosets manufacturing and test phases.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: 12032736
• MDR Text Key: 264052165
• Report Number: 3003752502-2021-00008
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 8034013782020
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• 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: 6944908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1