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

Model Number 100170048

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2019

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 after the patient went on ecmo the nurse noted a growing spot of blood on the floor under the oxygenator.The nurse checked the caps, and nothing was loose.They could see an obvious drip but no clear source of the leak.They opted to exchange it.No additional information was reported.

Manufacturer Narrative

Manufacturer's investigation conclusion: the production documentation for amg pmp oxygenator, lot number 5830806, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.The report of a blood leak could not be confirmed and no device-related issues were discovered during the evaluation of the returned oxygenator.The eurosets amg pmp oxygenator, lot number 5830806, was returned to abbott and an initial visual inspection was performed.Visual inspection of the oxygenator showed no obvious cracks or damage to the external housing or ports.The oxygenator was then forwarded to the external manufacturer for technical analysis.Upon receipt at eurosets, the oxygenator was cleaned and dried before proceeding with the functional test.The test circuit was filled with physiological water and an initial flow of 4 lpm was established.After 30 minutes of operation, no leaks from the oxygenator were identified.The flow was then increased to the maximum recommended flow of 7 lpm as indicated in the amg module pmp ifu, and a counter pressure at the blood outlet of the oxygenator was applied by partially clamping the connector at the blood outlet of the oxygenator.After 2 hours of operation, no leaks from the oxygenator were identified.Functional testing of the oxygenator revealed no source of leakage and the manufacturer determined that the device was compliant with product 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: 9548296
• MDR Text Key: 174606168
• Report Number: 2916596-2020-00014
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 100170048
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention