MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number US5062

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that upon priming the amg/pmp oxygenator, leaking of fluid in lower (orange) portion of the oxygenator was noted.Oxygenator was not used on a patient and was set aside to send back to abbott.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported leak was confirmed based on the submitted video; however, the manufacturer could not reproduce any leakage during testing of the returned oxygenator.The eurosets amg pmp oxygenator, lot number 6183306, was returned to abbott and an initial visual inspection was performed.Visual inspection of the oxygenator showed no obvious cracks or damage to the external housing or ports.The oxygenator was then forwarded to the external manufacturer for technical analysis.The oxygenator was filled and pressurized at 400 mmhg and no leaks were immediately detected.The oxygenator was then pressurized at 1 atm for 1 hour and no leaks were observed.The test circuit was then filled with physiological water and an initial flow of 4 lpm was established.After 2 hours of operation, no leaks from the oxygenator were identified.The flow was then increased to the maximum recommended flow of 7 lpm as indicated in the amg module pmp ifu, and a counter pressure at the blood outlet of the oxygenator was applied by partially clamping the connector at the blood outlet of the oxygenator.After 3 hours of operation, no leaks from the oxygenator were identified.Functional testing of the oxygenator did not confirm a source of leakage and the manufacturer determined that the device was compliant with product specifications.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 applies the production process tests to one hundred percent of their manufactured oxygenators.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.The production documentation for amg pmp oxygenator, lot number 6183306, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.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: 10600360
• MDR Text Key: 208976234
• Report Number: 3003752502-2020-04148
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 08034013782020
• Combination Product (y/n): N
• PMA/PMN Number: K141492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 6183306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1