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

Catalog Number	046005201
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the discovery that the issue was related to a livanova usa component, the purge line was returned to livanova usa from sorin group (b)(4) for evaluation.Visual inspection found that there was a large, spiraling crack in the male slip portion of the r-angled male luer.The crack was found to run the entire length of the luer slip and caused the device to leak at minimal pressures.The instructions for use for the heart/lung perfusion packs clearly state, ¿all luer connections should be finger-tight.Over-tightened connections may result in cracks or leaks.Wet connections promote over-tightening by lubricating the ports.¿ all caps, luers, breathers and connections are properly secured during the product assembly process.However, thermal stresses encountered during sterilization and storage after product release could, in some instances, cause the mating of these parts to change resulting in looser connections.The instructions for use also states under the precautions and procedures for use section that, prior to use, the user should ¿check for loose connections on pre-assembled packs¿ and ¿tighten luer locks and luer fittings to the desired components finger-tight.Do not over-tighten.¿ all of the evidence presented by the returned product strongly suggests over-tightening, possibly due to wet connections.
Event or Problem Description
Livanova usa received a report that a leak was identified at the male luer on the oxygenator purge line of the customer perfusion tubing set.The user tightened the connection of the line to the oxygenator and went on bypass.Despite several attempts to tighten the line, the leak was observed again during the case and the oxygenator was changed out.This event was initially reported by sorin group (b)(4) against the inspire oxygenator (see 9680841-2017-00032).However, during complaint evaluation, it was discovered that the issue was related to the male luer supplied by livanova usa.The patient received 4 units of blood.There was no report of patient injury.

• 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: 7319847
• Report Number: 1718850-2018-00006
• Device Sequence Number: 16545517
• Product Code: DWE
• UDI-Device Identifier: 00803622133312
• UDI-Public: (01)00803622133312(240)046005201(17)190930(10)1725600053
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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: 09/30/2019
• Device Catalogue Number: 046005201
• Device Lot Number: 1725600053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1