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

Model Number US5062

Device Problems Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the oxygenator had non-uniform appearance of the fibers.The customer reported a reddish colored vertical line in the body of the oxygenator visible from the outside.Additionally, a cluster of white oxygenator fibers were visible in the "lower band" of the oxygenator close to the arterial outlet.The fibers appeared to protrude into the blood path.The customer was concerned this obstruction could lead to thrombus formation.Finally, the customer noted an excessive amount of condensation coming from the bottom of the oxygenator.The customer drew additional pre and post blood gasses.

Manufacturer Narrative

Manufacturer's investigation conclusion: through review of the available information and submitted images, the external manufacturer (eurosets) determined that there is no fault related to the oxygenator.The submitted oxygenator photos show a cluster of white fibers visible just above the bottom housing, as well as a reddish colored vertical line in the body of the oxygenator.Condensation is also visible within the bottom housing.It was later reported by the account that the eurosets amg (advanced membrane gas exchange) pmp (polymethylpentene) oxygenator, lot 7559308, would not be returned for evaluation.Based only on the available information, the manufacturer (eurosets) determined that there is no fault related to the oxygenator.The reddish area is due to the geometric characteristics of the fiber bundle, and the humidity in the lower part of the oxygenator is a normal condition due the heat exchanger.The production documentation for amg pmp oxygenator, was reviewed by the external manufacturer (eurosets) 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.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.

Event Description

Additional information was received that the oxygenator was not exchanged.The patient was explanted and eventually discharged to rehab.

• 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
• Manufacturer (Section G): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17439143
• MDR Text Key: 320247878
• Report Number: 3003752502-2023-02393
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 08034013782020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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 Model Number: US5062
• Device Lot Number: 7559308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 80 KG