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

Model Number	CMAEK00
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
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 the customer was setting up centrimag pre-connected pack serial number (b)(6) to prime for use and the plastic clamshell that is passed to the field opened up.This exposed the sterile portion of the circuit.Subsequently the pack had to be scrapped, and another pre-connected pack was used.
Additional Manufacturer Narrative
Section d3: manufacturer information corrected.Section g1: manufacturing site corrected.Section g8: the initial report was incorrectly submitted with a fei-based manufacturer report (mfr) number: 3003306248-202x-xxxxx.The mfr number should have been cfn-based with the 7-digit cfn being 2916596.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
H6 correction: medical device problem code 2975 - manufacturing, packaging or shipping problem added.Manufacturer's investigation conclusion: the report of the packaging opening was unable to be confirmed through this evaluation, and a specific cause for the reported event could not be conclusively determined.The centrimag pre-connected pack was not returned for evaluation.The relevant sections of the device history records for centrimag adult extracorporeal membrane oxygenation (ecmo) kit (cmaek), serial number (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 describes that all components are provided sterile.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.-always handle the pack in an aseptic manner.-pack replacement should be prescribed by the physician based on risks and benefits to the patient.-use aseptic technique during all pack replacement procedures.Under the section titled ¿package inspection¿ the ifu instructs 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 ¿sterilization¿ the ifu informs that the pack contents have been sterilized with ethylene oxide before shipment.The contents including the accessories are for single use only and are not intended to be resterilized.If the sterile package has been compromised, do not use the product and contact technical support.The section titled ¿centrimag¿ pre-connected pack setup and operation¿ instructs that the centrimag¿ pre-connected pack should be set up in a clean and aseptic work area before you set up and use the circuit.This section describes how to peel back the tray cover and remove the tray retainers.Observing aseptic technique, connect any accessories or components selected by trained personnel to the circuit, and secure all connections.Under the subsection titled ¿prime the centrimag¿ pre-connected pack,¿ the ifu instructs to use aseptic technique to open the tubing tray lid by carefully lifting open each corner of the lid.Do not use excessive force to open the tubing tray lid.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.
Event or Problem Description
Clarification was provided that the plastic clamshell was a separate container in the pre-connected pack which houses the most sterile portion of the pack.This was the tubing that was connected to the cannula which was used to access the patient's circulatory system.The cause of the event seemed to be a manufacturing issue because the clamshell was not opening as expected.It was thought it should take some effort to open the pack.The customer observed that the clamshell opened up on its own.No photos were available.

• 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: 21161196
• Report Number: 3003306248-2024-07210
• Device Sequence Number: 15583718
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(17)260529
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/29/2025

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: 05/29/2026
• Device Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• Device Lot Number: 10451609
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 03/17/2025; 05/06/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 04/08/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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