MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG ADULT ECMO KIT (US); OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	CMAEK00
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a4: there was no patient involved.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 during priming for a pre-connected pack (pcp) for an extracorporeal membrane oxygenation (ecmo) patient, whistling from the oxygenator was heard.The oxygenator was not used after priming as it did not seem correct; the pcp was not placed on a patient.
Additional Manufacturer Narrative
D4; sn updated no further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Sections d3 and g1: manufacturer information corrected.Section d9: corrected.Section g4: there was no patient involved in this event.The pma # provided is associated with the device¿s most recent approval.Section g8: the initial report was incorrectly submitted with a fei-based manufacturer report (mfr) number: 3003752502-202x-xxxxx.The mfr number should have been cfn-based with the 7-digit fei being 2916596.Manufacturer¿s investigation conclusion: evaluation of the returned oxygenator was unable to confirm the reported sound.A specific cause for the reported event could not be determined through this evaluation.The cmaek oxygenator was returned to abbott, and visual inspection of the oxygenator revealed no obvious damage.The returned oxygenator was placed on a mock loop with saline using test centrimag equipment.Speed was adjusted from 2500-5500 revolutions per minute (rpm), and flow was adjusted from 0.5-5.0 liters per minute (lpm); however, no abnormal sounds were able to be discerned.The oxygenator was returned to the supplier (eurosets) for technical investigation.A functional test of the oxygenator was performed on a test circuit with bovine blood and found that the oxygenator was compliant with the reference values.Eurosets concluded that the technical investigation confirmed that the claimed device was compliant with the technical specification and for that reason they were not able to confirm the complaint by the customer.The relevant sections of the device history records for the cmaek serial # (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag pre-connected pack instructions for use (ifu) rev.B, 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.Under the section titled ¿prime the centrimag pre-connected pack,¿ the ifu warns to monitor the circuit for leaks or other product anomalies.Replace the pack if it does not operate as expected.The current revisions of the 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): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20410444
• Report Number: 3003752502-2024-00030
• Device Sequence Number: 21093418
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(10)10118082(17)241104
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K020271
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2025

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 Expiration Date: 11/04/2024
• Device Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• Device Lot Number: 10118082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 12/11/2024; 04/28/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 01/02/2025; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2023
• 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