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

Model Number US5062

Device Problems Mechanical Problem (1384); Contamination /Decontamination Problem (2895)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2020

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 the account was unable to draw or flush the post oxygenator sampling pigtail.There was not any.After multiple attempts, the perfusionist was able to withdraw blood from the pigtail, but was unable to flush the blood back.Upon close inspection, the account reported a white object in the outlet.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the submitted photographs confirmed the presence of an incorrectly placed one-way valve in the outlet luer port, which would have contributed to the reported difficulty back-flushing into the circuit.The external manufacturer concluded that based on the internal investigation, it was assumed that 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.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 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.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.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: 10582222
• MDR Text Key: 208417362
• Report Number: 3003752502-2020-04146
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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 Catalogue Number: US5062
• Device Lot Number: 6013706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 66