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

Model Number US5062

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that the oxygenator started leaking a few minutes after priming and before initiation.The leak was noted an inch below the arterial at the level where the orange plastic meets the white, internal to the orange cover.The oxygenator had not been water tested prior to use and was not hooked up to a heat exchanger due to a battery test that was being run.

Manufacturer Narrative

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

• Brand Name: ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
• Type of Device: CONTROL, PUMP SPEED, 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18861268
• MDR Text Key: 337649912
• Report Number: 3003752502-2024-00010
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 8034013782020
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 009351508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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