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

Catalog Number	044009103
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypovolemia (2243)
Date of Event	09/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.Sorin group italia manufactures the smart perfusion pack.The incident occurred in the (b)(6) united states of america.During follow up with the customer, on september 28, 2022, sorin group italia was informed that the leakage occurred nearly 30 minutes after being on pump (bypass) and appeared to be originated from the one way valve, as it split in half.Perfusionist said it was very difficult to tell what happened because there was so much blood everywhere.Medical team decided to administer units of blood to patient.The patient is fine.The circuit has been disposed after the case.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Sorin group italia received a report that, on (b)(6) 2022, about 30 minutes since on pump, the purge line began leaking.The perfusionist occluded the line and stop blood loss in about 20-30 secs.However, an estimated 500ml was lost.Upon inspection, the one-way valve was split in half.The case was completed without further incident and the patient come off bypass successfully.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova received a report stating that, during a procedure, a leak from the purge/recirculation line of the inspire oxygenator was identified.The one-way valve split open in the middle.Patient was administered of heterologous blood to compensate blood loss.There is no report of any patient injury.The unit is not available.However, at the submission of the case, the customer has provided pictures confirming the reported issue.The dhr of the circuit confirmed the device was released conforming to specifications.Review of the livanova complaint database did not identify any other similar event relevant to the complained circuit.Based on the pictures received, most likely root cause of the reported event was a welding issue of the one-way valve or a damage during transportation.The complained purge/recirculation line is supplied by a livanova supplier.The supplier has been formally informed of the event.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: PERFUSION PACKS
• Common Device Name: SMART, PERFUSION PACKS, CONNECTORS, 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: 15672370
• Report Number: 1718850-2022-00056
• Device Sequence Number: 15077351
• Product Code: DWE
• UDI-Device Identifier: 00803622142550
• UDI-Public: (01)00803622142550(240)044009103(17)240831(10)2223600055
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 044009103
• Device Lot Number: 2223600055
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 10/29/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown