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

Catalog Number	627355902
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information has been provided.Livanova usa inc manufactures the complained circuit.The incident occurred in (b)(6) united states of america.Device availability was not clarified.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc has received a report that, during long term support, the tubing came off of the outlet of the oxygenator and approximately one unit of blood was lost; the tubing was reconnected, and support resumed.Livanova has requested to receive the disconnected tubing for investigation.There is no information on patient outcome.
Additional Manufacturer Narrative
Through the follow-up with the customer, livanova has learned that the connection that disconnected during the case is manually assembled by the customer to the outlet of a competitor oxygenator and secured with a tie band.No photographic evidence not any video of the even was provided.The unit was not made available for return and therefore no physical investigation on the unit could be performed.The dhr review confirmed that the lot was released conforming to product specifications.The analysis of the livanova complaints database revealed that no other similar complaint relevant to this circuit catalog item has ever been received.Based on all the above facts, it cannot be ruled out that a suboptimal connection by the customer might have contributed to the reported event.However, overpressure condition at the oxygenator outlet or a deviation in the chemical characteristics of the tubing could not be completely ruled out.The risk is in the acceptable region.Livanova will keep monitoring the market.
Event or Problem Description
See intial report.

• Brand Name: SMART 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: 13651254
• Report Number: 1718850-2022-00022
• Device Sequence Number: 5780432
• Product Code: DWE
• UDI-Device Identifier: 00803622145988
• UDI-Public: (01)00803622145988(240)627355902(17)221130(10)2031500056
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: 11/30/2022
• Device Catalogue Number: 627355902
• Device Lot Number: 2031500056
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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