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

Event Date 07/07/2020

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

The site communicated that the they could not flush through the outlet pressure monitoring port.The amg was exchanged and the facility stated, "upon examination, there appears to be a one way valve in the outlet pressure monitoring port".Amg was disposed of due to covid-19 positive patient.

Manufacturer Narrative

Section a: patient information was requested but not provided.Manufacturer's investigation conclusion: the report of the presence of an incorrectly placed one-way valve in the outlet luer port leading to difficulty flushing through the outlet pressure monitoring port could not be confirmed through this investigation, as there were no photographs submitted for review, and the device was not returned for evaluation.It was reported that the perfusionist could not flush the outlet pressure monitoring port.Upon examination, there reportedly appeared to be a one-way valve in the outlet pressure monitoring port.It was reported that due to the patient¿s covid status, the eurosets amg pmp oxygenator, lot number 6013706, will not be returned for evaluation.The external manufacturer (eurosets) concluded that based on the internal investigation and reported information, the reported issue was due to the presence of a one-way valve in the outlet luer port which was placed in error during the manufacturing process.The external manufacturer initiated a corrective and preventative action (capa) to address the issue.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.The section titled "during bypass" states that for arterial blood sampling, connect a dedicated sampling line equipped with one-way valve (to allow suction only) to the female luer-lock connector (positioned on the arterial outlet).Under "circuit connections", the ifu warns that when performing arterial sampling, the arterial sampling line must be equipped with a one-way valve to prevent unwanted ingress of air.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 6013706, 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: 10332297
• MDR Text Key: 200622501
• Report Number: 2916596-2020-03841
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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: 12/31/2022
• Device Model Number: US5062
• Device Lot Number: 6013706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1