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

Model Number US5062

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

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 patient is covid-19 positive and was placed on ecmo with a circuit using a sorin revolution pump and the eurosets amg oxygenator.The clinician was unable to get adequate flow and requested to turn the rpm to max speed (4500) on the sorin system.This caused cavitation and deprimed the venous line to the pump and then subsequently deprimed the oxygenator.The clinician clamped out the circuit and exchanged the circuit with another pump and oxygenator and re-initiated support.The patient experienced a blood pressure drop until the circuit was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: visual inspection of the returned oxygenator did not reveal any device-related issues.The eurosets amg pmp oxygenator, lot number 5969906, was returned to abbott and a visual inspection was performed.The oxygenator was returned connected to the tubing circuit containing another manufacturer¿s blood pump.The oxygenator and circuit were filled with blood.Visual inspection of the oxygenator revealed no obvious damage to the external housing, ports, or fibers.No blood was observed within the top or bottom orange housing.The external manufacturer would not allow the device to be forwarded to their facility due to the patient being covid-19 positive; therefore, further analysis and functional testing of the oxygenator could not be performed.Of note, the reported information indicated that increasing the pump speed above the maximum caused cavitation and depriming of the circuit and there was no oxygenator failure.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.Per the reported information, the event was caused by a non-oxygenator related issue; there was no oxygenator failure.The ifu lists the following warnings: during the extracorporeal circulation (ecc) a backup oxygenator is necessary.Always, the extra corporeal circulation has to be carefully and continuously checked.The ifu contains a section titled "priming and recirculation procedure", which explains how to prime the circuit.Under the section titled "oxygenator replacement", the ifu 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 that 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: 10074224
• MDR Text Key: 192013861
• Report Number: 3003752502-2020-00002
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 08034013782020
• 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,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 120