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

Model Number US5062

Device Problem Insufficient Information (3190)

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

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the clinician noticed that the eurosets amg oxygenator had red foaming in the gas outlet chamber during their routine system check.The oxygenator performance was unaffected however an oxygenator explant kit is being requested as the plan is to return the oxygenator once off support for investigation.The clinician monitored to see if the red foamy discharge in the gas outlet chamber got worse and had a primed replacement oxygenator available in case an oxygenator change-out was needed.No additional information provided.

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 5969906, was returned to abbott and an initial visual inspection was performed.Visual inspection of the oxygenator revealed blood within the orange housing of the device near 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 for technical analysis.The oxygenator was cleaned of blood contamination then pressurized at 1 atmosphere (atm) and no leaks were immediately detected.The test circuit was then filled with physiological water and an initial flow of 4 liters per minute (lpm) was established.The oxygenator operated in the test loop for 3 hours and 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 heat exchanger and the gas-in and gas-out lid.Traces of clotted blood were observed that appeared to be a consequence of blood leakage due to a broken fiber.A specific root cause for the damage to the fiber that caused the reported leaking could not be conclusively determined through the manufacturer 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 5969906, 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.¿ the section "during bypass" warns that the act (activated coagulation time) must always be longer than or equal to 480 seconds in order to ensure adequate anticoagulation of the extracorporeal circuit.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: 10503218
• MDR Text Key: 206809412
• Report Number: 3003752502-2020-04145
• 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,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 5969906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 123