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

Catalog Number 627282602

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2019

Event Type  malfunction  

Manufacturer Narrative

Patient birth date was not provided.Patient weight was not provided.Customer telephone number (b)(6).Attempts have been made to gather additional information about the event from the customer.However, no additional information has been provided at this time.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova usa inc has been informed that, during changing medication line of an ecmo circuit, blood spilled from the stopcock when it was closed.Circuit was clamped for less than 30 seconds, the stopcock was changed and blood product were pushed to restore flows.Despite requested, livanova has not been informed of patient outcome.Livanova has received via us mail the report mw5083444.

Manufacturer Narrative

Livanova usa inc has been informed that, during changing medication line of an ecmo circuit, blood spilled from the stopcock when it was closed.Circuit was clamped for less than 30 seconds, the stopcock was changed and blood product were pushed to restore flows.Despite requested several times, livanova has not been informed nor of the patient outcome neither has received any additional information to clarify the event and/or sequence of events.Nor the complained device neither pictures were provided.A review of the dhr did not identify any deviation, non-conformity relevant with the case.No other similar complaint has been received for the claimed product lot.As the issue claimed by the customer could not be clarified and the complained device was not made available for investigation, the complaint cannot be confirmed.Livanova will keep monitoring the market for similar events.Device not available.

• Brand Name: CUSTOM PERFUSION TUBING SET
• Type of Device: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• 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: alessandro melchiorre ; 14401 w 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 8358353
• MDR Text Key: 136857278
• Report Number: 1718850-2019-00007
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 008036221237764
• UDI-Public: (01)008036221237764(240)627282602(17)200331(10)1806700057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 627282602
• Device Lot Number: 1806700057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR