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

Model Number	CMAEK00
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a: 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 set up of a new pre-connected pack, the pigtails accessory was missing from the new pack.Pigtails were pulled from another kit.There was no delay in procedure due to this event.There was no adverse patient impact.
Additional Manufacturer Narrative
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 cfn being (b)(4).Manufacturer's investigation conclusion: the reported event of the pigtails missing from the pre-connected pack was unable to be confirmed.A specific cause for the reported event could not be conclusively determined through this evaluation.The account submitted one image of the outside of the box for the pre-connected pack, confirming that the product had model number cmaek00, serial number (b)(6).The reported event could not be confirmed based on the image.Review of the device history records for the centrimag adult extracorporeal membrane oxygenation (ecmo) kit (cmaek), revealed no deviations from manufacturing or quality assurance specifications.A specific cause for the reported event could not be conclusively determined.The relevant sections of the device history record (dhr) for the centrimag adult extracorporeal membrane oxygenation (ecmo) kit (cmaek), serial #(b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag adult extracorporeal membrane oxygenation kit instructions for use (ifu), rev.B, is currently available.The ifu contains the following general warnings: -only trained personnel should use the circuit.-a backup circuit must be available immediately near the primary circuit during ecmo support.-component replacement should be prescribed by the physician based on risks and benefits to the patient.Under the section titled ¿package inspection,¿ the ifu warns to inspect the package carefully before opening.If the integrity of the sterile package has been compromised, or the product and/or package is defective, do not use the product and contact technical support.Under the section titled ¿package contents,¿ the ifu says that the package contains four high-flow pigtails with 3-way stopcock.The pigtails are listed as an accessory under this section.No further information was provided.The manufacturer is closing the file on this event.
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 additionally reported that both pouches of pigtails were missing.

• 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: 23439174
• Report Number: 3003752502-2025-00036
• Device Sequence Number: 8672237
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(17)270103
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222297
• 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): 12/23/2025

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 Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• Device Lot Number: 10805523
• 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: 10/12/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 12/22/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/01/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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