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

Model Number US5062

Device Problem Mechanical Problem (1384)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/09/2021

Event Type  Injury  

Event Description

It was reported that while flushing of the amg purge line the ecmo specialist was using the slide clamp to occlude the purge line as per routine and blood starting spraying out of the a small split in the silastic under the slide clamp.She was able to stop the bleeding with direct pressure with her fingers and called for help.The perfusionist came to the bedside and was able to remove the section of the purge line that had the split with 1/4 inch connector and tubing.The purge line was secured at that time and no more blood was noted to be leaking from the oxygenator.The patient tolerated the procedure very well and ecmo was not stopped or clamped throughout the event.The oxygenator is still in use and the patient is on active covid isolation so the product will not be returning for evaluation.

Manufacturer Narrative

Section d4: correction.The serial number field was incorrectly filled with the lot number in the previous report.Serial number not applicable.Manufacturer's investigation conclusion: review of the submitted photos of the eurosets amg (advanced membrane gas exchange) pmp (polymethyl pentene) oxygenator confirmed the report of a damaged purge line; however, the submitted photos showed the purge line after the account repaired the damage with a connector and new tubing.A specific root cause for the damaged purge line could not be conclusively determined through this evaluation.Review of the submitted oxygenator photos showed the repaired purge line.The original purge line was connected to the purge line port and was cut all the way around at approximately 1.5¿ from the oxygenator housing.A connector with tubing was attached to the section of the original purge line, secured with zip ties.No other abnormalities or damage was noted.The eurosets amg pmp oxygenator, lot # 6649207, remained in use following the reported event, and the oxygenator would reportedly not be returned for evaluation as the patient was in isolation for a viral infection.Eurosets checked the production documentation related to the claimed lot and confirmed that all tests made in the production process were compliant with the technical specification.Eurosets confirmed that they apply the 100% production process test to all of their devices.Based on the information provided by the customer, eurosets was not able to identify the root cause of the problem.The eurosets amg pmp instructions for use (ifu), rev.04, is currently available.Under the section titled, ¿intended use¿, the ifu states that the ¿a.M.G.Module pmp no t.P.Sterile is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours¿ and also that the device ¿is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.Contact with blood for a longer period of time is unadvisable.¿ 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.Under the section titled, ¿priming and recirculation procedure¿, the ifu provides instructions on how to prime the oxygenator for use including 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 title, ¿during bypass¿, the ifu provides instructions on how to purge air using the purge line and clamp.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.

Event Description

The patient began extracorporeal membrane oxygenation (ecmo) support on (b)(6) 2021.A centrimag device operated in the ecmo circuit at 5200 revolutions per minute with flow of 6.3 liters per minute with a eurosets amg pmp oxygenator.The pressure at the blood inlet port was reportedly 400 millimeters of mercury.On (b)(6) 2021, the slide clamp was being used to occlude the purge line following flushing of the purge line per routine.A small split in the silastic of the purge line under the slide clamp was discovered as blood started spraying out of the slit.The purge line was replaced with 1/4 inch connector and tubing, which resolved the blood leak.It was reported that the patient tolerated the procedure very well, and the ecmo circuit was not stopped or clamped throughout the 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: 11769640
• MDR Text Key: 248824296
• Report Number: 0002916596-2021-02385
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: US5062
• Device Lot Number: 6649207
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 104