MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR COSTA RICA LLC TERUMO CARDIOVASCULAR PROCEDURE KIT; CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK

Model Number	64725
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the perfusionist, the patient was on extracorporeal membrane oxygenation (ecmo) after a norwood procedure.The alarm for low pressure sounded and the perfusionist noted that the connector had been dislodged at the connection point to the oxygenator and the blood loss was noted at that time.It was assumed that the connection point loosened over time or through patient movement/torque as neither device was cracked or broken.The product was returned and photos were provided of the reported product.The component was seen to be in good condition and no damage was seen on the component that could have led to dislodgement.Additional testing was performed on five sample units that were built to replicate the reported part number.Following testing, no leaks or dislodgements were noted.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the connector dislodged from a leur fitting on the venous inlet to the oxygenator.The lines were clamped while a new connector was primed and replaced.The flow was returned and the patient returned back to baseline.The surgical procedure was completed successfully.There was a blood loss of about 100 milliliters (ml).There was no delay, nor adverse consequences to the patient.
Additional Manufacturer Narrative
During evaluation, the sample was bubble leak tested where the connection was made within a test loop, then placed underwater.The loop was pressurized and no leaks or bubbles were found, determining that when the connection was made appropriately, the connection was secure and did not leak.The device history record (dhr) was reviewed and no issues were noted related to this complaint.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Event or Problem Description
Per clinical review: this complaint from the user facility involved the manufacturer's pigtail connection that became dislodged on a eurosets extracorporeal membrane oxygenation (ecmo) oxygenator during ecmo (bypass).The pigtail was connected to the venous inlet port of the oxygenator.There was a 100 milliliter (ml) loss of blood to the patient.The clinician clamped the tubing lines to stop the blood loss and stop ecmo, so that the pigtail connection could be changed out.The patient was arrested during this time.Ecmo was successfully re-initiated.The pigtail connection was returned to the manufacturer for investigation.A picture was provided by the user.Upon inspection, there were no visible cracks or other damage on the pigtail connection.Five samples of the pigtail were tested, and no leaks were observed.Manufacturing records at that time revealed no anomalies.The complaint could not be replicated, and a definitive root cause could not be determined.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR COSTA RICA LLC; calle 58; cartago, zona franca la lima
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 18011917
• Report Number: 3017987980-2023-00002
• Device Sequence Number: 20652233
• Product Code: OEZ
• UDI-Device Identifier: 00699753457041
• UDI-Public: (01)00699753457041(10)0000340444(17)250228
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 64725
• Device Lot Number: 0000340444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EUROSETS NEONATE OXYGENATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Race: White