MAUDE Adverse Event Report: LIVANOVA USA INC PERFUSION PACK

Model Number	044016205
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H.11.Livanova manufactures perfusion pack.According to customer, at the conclusion of the procedure, the circuit was inspected and the oxygenator and relevant lines were isolated.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 received a report that, during a cpb, the arterial line became dislodged from the arterial outlet of the oxygenator, leading to some blood loss and the necessary discontinuation of cpb for approximately four minutes.The line was reconnected and tie-banded in a timely manner.The circuit was prepped and inspected for safety.Once it was determined that it was safe to do so, cpb was reinstituted with the cooperation of the surgeon.There is no report of any patient injury: daily follow-up for three consecutive days reveals no neurological or other deficits in the patient.This has also been confirmed in discussions with the cardiac surgeon.
Additional Manufacturer Narrative
H11: unit was returned to livanova for investigation.Upon initial inspection, it was observed that the returned sample was tie-banded, and solvent was confirmed to be present.The tie-band found on the sample was likely the one applied by the customer.A review of the drawing for the involved perfusion tubing system (pts) catalog number confirmed that this affected line is assembled using both a tie-band and solvent.The tie-band present on the sample was cut, and it was found that the tubing attached to the arterial outlet was easily removable.During assembly, operator utilizes a tubing stretcher to facilitate the connection between the tubing and hard connectors.Over-use of the tubing stretcher could be a potential cause of the ease of removal observed in the returned sample.The review of the complaints database identified that no other similar incidents were notified for concerned batch nor pts catalogue number, neither a concerning trend was detected.Based on the available data, the most likely root cause of the complained event was an improper assembly of the arterial line to the connector.It is likely that the disconnection occurred due to the tie-band not being properly fastened, combined with the potential over-use of the tubing stretcher, which may have resulted in a loose connection between the tubing and the hard connector.To prevent re-occurrence, the manufacturing personnel has been involved in a dedicated training meeting to discuss the specific event.
Event or Problem Description
See initial report.

• Brand Name: PERFUSION PACK
• Common Device Name: PERFUSION PACK
• 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: 20809274
• Report Number: 1718850-2024-00044
• Device Sequence Number: 15778370
• Product Code: DWE
• UDI-Device Identifier: 00803622142352
• UDI-Public: (01)00803622142352(240)044016205(17)260813(10)2422600116(11)240813
• 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): 02/26/2025

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: 08/13/2026
• Device Model Number: 044016205
• Device Lot Number: 2422600116
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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: Required Intervention
• Patient Sex: Unknown