MAUDE Adverse Event Report: LIVANOVA USA INC COBE SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number	62725703
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypovolemia (2243)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sorin group italia manufactures the smart perfusion pack.The incident occurred in new hyde park, new york, united states of america.The complained circuit is not available for investigation.On (b)(6) 2022, sorin group italia received a user medwatch report (mw5111793) related to this issue.In the report, the provided lot and the catalogue item code do not match: the provided lot number corresponds to the catalogue item code 627257503 and not to 627257502 as indicated in the user medwatch report.Follow up with the customer could not clarify the item code.During the follow up the customer informed livanova the leak was from a connection.It was recommended to always secure connection with tie bands.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
On (b)(6) 2022, sorin group italia received a user medwatch report (mw5111793) stating that patient was being supported on veno-arterial extracorporeal membrane oxygenation (ecmo) and the ecmo circuit, which carries the blood from patient to oxygenator and back to the patient, developed a significant leak.Leak identified at bonded locations in the circuit.Significant blood loss which required change out of the circuit.
Additional Manufacturer Narrative
Livanova received the information that during support in ecmo, customer noticed that there was a significant leak caused by the disconnection from one of the 3/8¿x1/8¿ connectors that required change out of the circuit.Patient outcome was not clarified.Circuit is not available.No picture was received.The dhr review confirmed the complained lot was released conforming to product specification.By reviewing the complaints database no similar event was identified.According to the technical documentation of the complained circuit, the 3/8¿x1/8¿ connectors are secured to the tubing using solvent.As per ifu indications, the complained circuit is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours or shorter.Prolonged use of the device cannot be ruled out as possible root cause.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.H3 other text : disposed by the user.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
D.4.As per follow up with the customer the correct catalogue number is 62725703 and not 627257032 as per medwatch.H.10.The issue was a disconnection in ecmo from one of the 3/8¿x1/8¿ connectors.It was not clarified which exact connector failed.The length of time when it was disconnected or how much blood was lost or the patient outcome were not provided.Investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15623916
• Report Number: 1718850-2022-00055
• Device Sequence Number: 6460641
• Product Code: DWE
• UDI-Device Identifier: 00803622141089
• UDI-Public: (01)00803622141089(240)627257503(17)240630(10)2216500103
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 62725703
• Device Lot Number: 2216500103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 11/29/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/17/2022; 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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