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

Model Number	CMAEK00
Medical Device Problem Codes	Mechanical Problem (1384); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a new pre-connected pack (pcp) to prime prior to a case, priming bag was found to be punctured and oxygenator housing found to be cracked.A new pcp was primed for patient use.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported damage to the priming bag of the pre-connected pack was unable to be confirmed through the submitted images, and the pack was not returned for evaluation.A specific cause for the reported damage could not be conclusively determined.The submitted images were reviewed, which included an image of the priming bag; however, the reported puncture could not be conclusively confirmed through review of the image.It was reported that the centrimag pre-connected pack, serial (b)(6), would not be returned for evaluation.The centrimag pre-connected pack instructions for use (ifu) warns to not use excessive or damaging force when handling the pack.The ifu warns that a backup pack must be available immediately near the primary pack during support, and if a pack component is dropped and damaged, replace the pack.The relevant sections of the device history record (dhr) for the cmaek, serial (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The production documentation for the priming bag, eurosets lot #7835004 of eurosets model #eu6142/v, was also reviewed by the external manufacturer (eurosets) and showed that all tests made in the production process were compliant with the technical 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.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): 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: 21575729
• Report Number: 2916596-2025-01444
• Device Sequence Number: 8271816
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P170038
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: Lay User/Patient
• Device Expiration Date: 06/26/2026
• Device Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• Device Lot Number: 10552484
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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