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

Model Number US5062

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/29/2020

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 their was a call received from the surgeon at oschner medical foundation regarding fungus in an amg oxygenator.It was an oxygenator they primed on (b)(6) 2020 using isolyte crystalloid solution, using standard sterile techniques in the operating room area and didn't use it for 30 days.This circuit was used as an emergency back-up circuit for a patient on ecmo support.The site kept it primed until (b)(6) 2020 and decided to move it as a training loop.When they were doing this, they noticed a black mold/fungus visible on the surface of the membrane inside the sterile containment.Only one spot was noted.The surgeon admitted this could have come from contamination from them priming the oxygenator or from the manufacturing.The site circulated the fluid around the circuit and agitated the membrane to attempt to dislodge some of the organism, and then withdrew 60cc of the prime.It was spun and cultured, but no organisms were identified.The site then removed the device from the circuit and prepped the outer plastic with alcohol, and then used a small circular handsaw to split the plastic and obtain access to the contaminated area of the membrane.The involved membrane was cut out and sent to microbiology, where two genus of fungus were isolated.A third was later isolated as well.Ochsner tried to do their own testing but ended up getting the cdc and fda involved.The fda did not have other reports of this happening.They sent a brand new oxygenator to the cdc and they actually grew the same strain a fungus in a brand new oxygenator so that eliminates contamination from the ochsner team and they think it may have come from the manufacturing plant in italy.They are getting the fda back involved and also reporting to elso.Ochsner provided their draft medwatch report that reported they used standard sterile procedures to construct the circuits, but cannot rule out that they contaminated the oxygenator in this process.However, they reported it seemed very unusual that they would contaminate the fluid and have three separate and distinct organisms grow in a single location within the membrane.Similarly they cannot rule out primary contamination of the crystalloid prime, but using the same logic, would have expected several areas to grow.Primary contamination and inadequate sterilization of the polymethylpentene surface during manufacturing is a possibility, but which they cannot confirm.The cdc had searched for similar reports and found none.Ochsner also primed an identical device from the same lot number, and kept it for 2 months and observed no growth.However this device was also sent to the cdc and they successfully recovered the same exophiala species from that membrane.The involved device was never used on a patient, or even exposed to blood priming.

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the submitted image confirmed the presence of a black/green mass adhered to the device fibers, near the top of the fibers, but below the orange top housing.The mass was adjacent to the area of the device where the purge line attaches to the oxygenator housing.A direct cause for the observed black/green mass could not be conclusively determined through this evaluation.A second oxygenator device from the same lot number was primed by the hospital and observed for two months, with no growth.The second device was also sent to the cdc, where cultures yielded fungal growth.The amg pmp oxygenator device associated with the reported event was not returned to eurosets for technical investigation.However, a different device from the same production batch as the oxygenator associated with the complaint was returned for investigation.Product tests for sterility were performed on the oxygenator returned from the center in its original packaging, model# us5062, lot# 5969906f0207.No deviations were found.Sterility tests were also performed on two additional oxygenators with similar conditions of the device associated with the complaint.The tests resulted in no growth, sterile.The production documentation for amg pmp oxygenator, lot number 5969906, was reviewed by the external manufacturer, eurosets, and showed that all tests from the production process were compliant with the technical specifications.Per eurosets, ¿we confirm that we apply the 100% production process test to all our devices.¿ eurosets provided additional data regarding the measures taken throughout the manufacturing process to ensure sterilization of the device.Eurosets concluded that ¿these measures ensure that the risk of contamination of the device is highly improbable.¿ eurosets¿s investigation concluded the following: "based on the information available, and on the tests performed on the similar device received, we confirm that the problem that occurred was not related to the eurosets device." the eurosets amg pmp instructions for use (ifu), rev.04, is currently available.The ifu indicates serious adverse reactions and potential safety hazards for the practitioner and/or the patient, which may occur during proper use or misuse off the device and also the limitations of use and the measures to be adopted in such cases.Additionally, the ifu indicates that the user must take every possible precaution for safe and effective use of the device.The ifu contains the following information in the section titled ¿warnings¿: - carefully read the instructions before using the product.- store in a dry place between 0°c and 40°c.- fragile, handle with care - the product must only be used by adequately trained and qualified personnel.- eurosets does not assume any responsibility for problems arising from inexperience or improper use.- the product must be used according to these instructions.Eurosets is not responsible for damage deriving from incorrect use of the product.- the product was sterilized with ethylene oxide.Its sterility is guaranteed only if the package is not opened or damaged.- the device may only be used if sterile.If the device is supplied not sterile (in which case, the words ¿not sterile¿ will be indicated on the pack) contact eurosets or an authorized dealer to agree on a sterilization method.- before using the product it is advisable to carefully inspect it.Shipping and handling could cause structural and functional damage to the device.- the product is atoxic and non-pyrogenic.- the product is disposable and to be used only once on one patient.- do not resterilize or clean for reuse.- do not subject to further treatments.- improper reuse may cause cross-infections and alteration of the device performance.- avoid conditions of use which expose the blood to a temperature higher than 37°c.- check the expiry date on the label attached.Do not use the device after the date shown.- the device must be used immediately after opening the sterile packaging.- the device must be handled aseptically.- during extra corporeal circulation (ecc) a backup oxygenator is necessary.- always, the extra corporeal circulation has to be carefully and continuously checked.The production documentation for amg pmp oxygenator, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.Per eurosets, ¿we confirm that we apply the 100% production process test to all our devices.¿ furthermore, the bioburden test certificate and sterilization records for the lot were reviewed and did not reveal any issues or deviations.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: 10900512
• MDR Text Key: 243228007
• Report Number: 3003752502-2020-04154
• 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: 06/25/2021

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: 11/10/2022
• Device Model Number: US5062
• Device Lot Number: 5969906F0207
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1