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

Catalog Number	044064500
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Livanova usa inc manufactures the complained circuit.The incident occurred in (b)(6) united states of america.The device has been received at livanova (b)(4).Initial investigation result could not reproduce the claimed disconnection.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 a bypass, the quick connectors between the outlet of the revolution pump and the inlet of the oxygenator disconnected.The quick connectors were provided already tie banded.The patient was transfused with blood.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Livanova received a report stating that the quick connector disconnected during a procedure.The patient was transfused.The complained connection is manually done by the customer.The analysis of the livanova complaint database revealed that no other similar complaint on this circuit item code.Thus, suggesting this is an isolated event.The dhr review did not identify any issue.The complained quick connector was investigated at livanova and the reported condition could not be confirmed on the returned sample.The sample was pressurized to 15psi for six hours, a factor of safety of 1.5 to the rated 10psi of the pts pack and no disconnection or leaking was observed.The connector behaved as expected.Based on all the above facts, it cannot be ruled out that an improper connection done by the customer could have led to the reported disconnection.No device malfunction could be confirmed.Since the root cause was not identified, no specific action was deemed necessary.Livanova will keep monitoring the market.

• 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: 12672320
• Report Number: 1718850-2021-00047
• Device Sequence Number: 1309668
• Product Code: DWE
• UDI-Device Identifier: 00803622147814
• UDI-Public: (01)00803622147814(240)044064500(17)230831(10)2122400056
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 044064500
• Device Lot Number: 2122400056
• Was Device Available for Evaluation?: No
• 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: 09/23/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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 Sex: Unknown