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

Model Number US5062

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2020

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 during circuit assessment a pink tinged froth was noted coming out of the amg pmp oxygenator's gas exhaust port.The circuit was exchanged to a new oxygenator.

Manufacturer Narrative

Section d4: correction; the previous report included (b)(6), for the serial number but it is for lot number.

Manufacturer Narrative

Section a1, a3: patient information was requested but not provided.Manufacturer's investigation conclusion: review of a submitted photograph confirmed the report of pink tinged froth coming out of the oxygenator's gas outlet port.It was reported that during a circuit assessment on (b)(6) 2020, a pink tinged froth was noted coming out of the amg pmp oxygenator's gas exhaust port.Review of the submitted photograph showed a light pink frothy substance leaking from the gas outlet port, which appeared consistent with blood mixed with gas.No adverse patient consequences were reported by the center.Information provided indicated that the oxygenator was exchanged after 21 hours of support.The eurosets amg pmp oxygenator, lot number 5919306, was not returned for investigation; therefore, a specific cause for the reported blood leak could not be conclusively determined through this evaluation.However, the manufacturer indicated that this type of leak could have resulted from damage to a fiber that occurred at some point following the manufacturing and testing phases.The production documentation for amg pmp oxygenator, lot number 5919306, was reviewed by the manufacturer and showed that all tests from the production process were compliant with the technical specifications.The production documentation for amg pmp oxygenator, lot number 5919306, 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.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 section "during bypass" warns that the act (activated coagulation time) must always be longer than or equal to 480 seconds in order to ensure adequate anticoagulation of the extracorporeal 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: 10218986
• MDR Text Key: 197749050
• Report Number: 2916596-2020-03367
• 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,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 5919306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 89