MAUDE Adverse Event Report: EUROSETS S.R.L. CENTRIMAG ADULT ECMO KIT (US); OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	CMAEK00
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a: patient information was not provided.Section d4: expiration date and manufacture date (h4) will be provided upon investigation.The primary udi number in d4 is reflective of all available information.Section g3: it is unknown which device the patient was implanted with at the time of the event.The pma# provided is associated with most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that upon opening the preconnected pack (pcp) the perfusionist noticed a pin hole size opening in the middle of the prime bag.Fluid dripped out.As soon as the prime fluid was added it started dripping out, there were no flows at the time and this was not noticed upon initial inspection of opening the pack.The pack was opened, primed, and used immediately.The hole was patched with bone wax and used immediately for support with no delays and no issues to the patient.The pack was discarded afterwards.
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Manufacturer's investigation conclusion: the reported damage to the priming bag of the pre-connected pack was unable to be confirmed as no product or images were submitted for evaluation.A specific cause for the reported damage could not be conclusively determined.The centrimag pre-connected pack was not returned for evaluation as it was reportedly discarded.Valid identifying information for the product, such as lot or serial number, was not reported and was unable to be determined through this investigation.The centrimag pre-connected pack instructions for use (ifu) is currently available.The ifu contains the following general warnings: only trained personnel should use the pack.A backup pack must be available immediately near the primary pack during support.Do not use excessive or damaging force when handling the pack.If a pack component is dropped and damaged, replace the pack.The current revisions of the instructions for use (ifu) can also be found on the electronic ifu (eifu) page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG ADULT ECMO KIT (US)
• Common Device Name: 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22538984
• Report Number: 3003752502-2025-00031
• Device Sequence Number: 20701411
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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
• Operator of Device: Health Professional
• Device Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown