MAUDE Adverse Event Report: EUROSETS S.R.L. EUROSETS ( ABBOTT) AMG -PMP MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number US5062

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  malfunction  

Event Description

Fungal species grown in device (primed oxygenator prepared for extracorporeal support).No patient involved.On (b)(6) 2020, we primed an oxygenator for use with an ecmo circuit, using isolyte crystalloid solutions, using standard sterile techniques in the operating room area.This circuit was used as an emergency back-up circuit for a patient on ecmo support.The circuit in question was never used and was pulled from the clinical arena after 30 days, and set aside for training purposes.On (b)(6) a black spot was visible on the surface of the membrane inside the sterile containment.It appeared to be mold.Only one spot was noted.We 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.We 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.These were sent to the mycotic division of the cdc in (b)(6) who was now assisting us.They identified and speciated the three samples (growth dates are not exact).While we use standard sterile procedures to construct the circuits, we cannot rule out that we contaminated the oxygenator in this process.However, it seems very unusual that we would contaminate the fluid and have three separate and distinct organisms grow in a single location within the membrane.Similarly we 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 we cannot confirm.The cdc had searched for similar reports and found none.We 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.To reiterate, the involved device was never used on a patient, or even exposed to blood priming, we have notified abbott, who distributes the eurosets amg-pmp in the united states (the device is manufactured in medolina italy) ongoing studies are in place with the remaining devices from the same lot in coordination with the mycotic division of the cdc.We have not notified the makers of isolyte solution.Although we cannot completely rule out that as a source for the fungus, and we did not have the lot number from the original bag used for the first circuit, now that the second membrane also grew the same fungus months later, we believe it is very unlikely that the electrolyte solution was the original source of contamination.Abbott laboratories, (b)(4).

• Brand Name: EUROSETS ( ABBOTT) AMG -PMP MEMBRANE OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EUROSETS S.R.L.
• MDR Report Key: 10945746
• MDR Text Key: 220007221
• Report Number: MW5098203
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: US5062
• Device Lot Number: 5969906F0207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1