MAUDE Adverse Event Report: LIVANOVA USA INC. SMART, PERFUSION PACKS, CONNECTORS, TUBING

Model Number	044065600
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.10.Livanova manufactures the smart perfusion pack.The incident occurred in usa.A livanova medical assessment for present event was conducted and confirmed the event to be reportable as serious injury as per currently available information.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received a report that, during a lung transplant procedure, a circuit line disconnected from the oxygenator.The event caused massive patient blood loss.
Additional Manufacturer Narrative
No evidence of the event was provided, nor any response or additional information received from the customer.As per techinical documentation of the customized circuit, the connection of the inlet and outlet of the inspire 6f oxygenator to the relevant tubing is performed by the customer during the assemebly of the circuit.According to the inspire oxygenator ifu, all connections must be secured by means of tie straps.Analysis of complaints database revealed that no other similar case was notified for batch concerned, nor for this customized circuit ite.No concerning trend has been identified.Based on the above, considering that complained connection is not performed in livanova manufacturing, the most likely root cause of the disconnection was an improper connection assembled by the customer at their facility.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: SMART, PERFUSION PACKS, CONNECTORS, TUBING
• Common Device Name: TUBING
• 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: 19938269
• Report Number: 1718850-2024-00035
• Device Sequence Number: 20056228
• Product Code: DWE
• UDI-Device Identifier: 00803622148651
• UDI-Public: (01)00803622148651(240)044065600(17)260201(10)2403300056(11)240202
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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 Model Number: 044065600
• Device Lot Number: 2403300056
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 10/20/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 65 KG