MAUDE Adverse Event Report: LIVANOVA USA INC SMART PERFUSION PACK; TUBING

Model Number	046006500
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa received a report that a pump boot tubing split during the case.They were almost off bypass and were able to come off.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures the smart tubing.The incident occurred in united states.After this happened, two packs with a kink or imperfection were found as per follow up with the customer, the customer was using a s5 roller pump and the perfusionist claims the occlusion was set properly.A technician checked the machine and over-occlusion cannot be excluded.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Visual inspection of the returned pack indicated this pack was not used since not even priming residues were present.Visual inspection of the returned pack found the main arterial tubing (luge tubing) had two indents and a kink.All three issues appeared to be caused by other components pressing against the line, during sterilization and shipment, causing the indentations.Based on the description we should probably look at adding a shelf over the luge tubing to prevent any of the components causing imperfections on the tubing.The dhr review the lot was released conforming to product specifications.Review of the livanova complaint database identified a previous event involving the same item catalogue circuit (1718850-2023-00032).Livanova is evaluating to optimize the circuit pack configuration to prevent the above tube damage.Based on the above, it cannot be ruled out that the reported event was caused by a sub-optimal package configuration caused by the interaction of the tubing with other components during sterilization/transport.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: SMART PERFUSION PACK
• Common Device Name: TUBING
• Manufacturer (Section D): LIVANOVA USA INC; 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: 17425357
• Report Number: 1718850-2023-00033
• Device Sequence Number: 7721307
• Product Code: DWE
• UDI-Device Identifier: 00803622133909
• UDI-Public: (01)00803622133909(240)046006500(17)250508(10)2312900178(11)230508
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/14/2023

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: 05/08/2025
• Device Model Number: 046006500
• Device Lot Number: 2312900178
• Was Device Available for Evaluation?: Yes
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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
• Patient Sex: Unknown