MAUDE Adverse Event Report: LIVANOVA USA, INC. CUSTOM PERFUSION TUBING SET; CARDIOPULMONARY BYPASS CUSTOM TUBING KIT

Catalog Number	044010901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/22/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Attempts have been made to gather additional information about the event from the customer.However, no additional information has been provided at this time.It is unknown how the patient died, how the product was involved, and if a device malfunction actually occurred.The user reported that a single unused pack from the same lot is available for return to livanova usa for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.
Event or Problem Description
Livanova received a report that a patient was concerned regarding "unexpected bad outcomes" that may or may not be related to the customer perfusion tubing set.According to the report, an inspection of the device by the perfusion staff did not identify any visible abnormalities.The report indicated that a patient had expired, though no further details about the event have been provided.
Additional Manufacturer Narrative
During follow-up communication with the customer, livanova learned that the report was filed because the surgeon felt that something was wrong with the pack.The contact stated that the surgeon did not have an idea as to what the issue might be.The customer reported that the patient was put on a left-ventricular assist device (lvad) on the second day following the procedure, and that the patient had been deteriorating for a couple days post-op with renal failure.The customer stated that it is unknown if the death was related to a malfunction of the device.Livanova reached out to a medical expert for a medical opinion on the event.The medical expert suggested that the issue appears to be potentially related to myocardial protection rather than perfusion.Further follow-up was conducted with the customer to obtain details on the myocardial protection.The customer stated that there has been a recent change in cardioplegia where the amount of magnesium was increased.The customer has since lowered the values back to the original levels.The data provided for myocardial protection and cross-clamp times was provided to the medical expert for review.After analyzing the data, the medical expert suggested that the cross-clamp time was high, which may contribute to myocardial infarction with impaired left-ventricular function, especially if in combination with a sub-optimal myocardial protection.At this time, it is still unclear what caused the patient death, and whether or not there was any device malfunction.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
One unopened, unused pack, custom perfusion tubing set from catalog 044010901, lot 1721500049, was returned to livanova for evaluation.As there was no specific malfunction reported by the customer, the entire contents of the pack were tested.The components of the pack were removed and assembled as they would be for clinical use.A similar device was also tested as a control.The circuits were primed and de-bubbled with sterile prime solution.Through 5 minutes of circulation, the prime remained free of visible debris and free of any abnormal coloring.No abnormal bubbling was observed in either unit circuit.The prime solution was replaced with bovine blood and the revolution pumps were set to circulate at 5 lpm.After circulating under clinically significant conditions for some time, the blood was evaluated for activated clotting time, platelet counts, and plasma free hemoglobin at the beginning and end of the test.The circuits were then drained and inspected for any abnormal clotting or thrombus formation.No thrombus or clotting was identified in the circuits.The surface of the blood in both reservoirs remained free of foam.No turbulence was observed within the reservoirs during circulation.No abnormalities with regards to blood chemistry, activated clotting times, platelet counts, or plasma free hemoglobins were found.No defects, deformities, or mis-assemblies of the returned pack were noted.No malfunctions, blood chemistry outcome abnormalities or structural concerns were found.As no malfunctions were identified with the product, a root cause could not be identified.

• Brand Name: CUSTOM PERFUSION TUBING SET
• Common Device Name: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 7319846
• Report Number: 1718850-2018-00005
• Device Sequence Number: 120046
• Product Code: DWE
• UDI-Device Identifier: 00803622133718
• UDI-Public: (01)00803622133718(240)044010901(17)190831(10)1721500049
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2018

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: 08/31/2019
• Device Catalogue Number: 044010901
• Device Lot Number: 1721500049
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/07/2018; 05/07/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/05/2018; 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death