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

Catalog Number	046001104
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Issue occurred prior to patient involvement.The involved device is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not available.
Event or Problem Description
Livanova usa in has received a report that, during the test before initiating the procedure, it was found that the arterial and the venous lines were swapped they rectified it by switching the 3/8" tubing on the arterial and venous cannulas.The issue occurred prior to any patient involvement.
Additional Manufacturer Narrative
The complained device was not made available for investigation.The customer has provided photographic evidence in which it is visible that the arterial and venous lines were swapped when compared with the technical drawing of the circuit.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.No other similar complaint has been received for the claimed circuit and/or lot.Livanova investigation confirmed the reported condition.The most probable root cause of the claimed issue was an isolated human error during the manual assembly of this specific unit of this item circuit.To prevent further occurrences,along with the already present in process control, the involved operators will be retrained.Livanova will keep monitoring the market.

• Brand Name: SMART, PERFUSION PACKS, CONNECTORS, TUBING
• Common Device Name: COBE SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 9422668
• Report Number: 1718850-2019-00024
• Device Sequence Number: 18958465
• Product Code: DWE
• UDI-Device Identifier: 00803622142840
• UDI-Public: (01)00803622142840(240)046001104(17)210731(10)1921300041
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 07/31/2021
• Device Catalogue Number: 046001104
• Device Lot Number: 1921300041
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1