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

Catalog Number 627199102

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

No patient information has been provided.A review of the dhr was not possible as no lot was provided.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 received a report that, during support, the tubing disconnected from the outlet of the oxygenator (maquet quadrox).The patient was administered of blood bank.There is no report of any patient injury.

Manufacturer Narrative

Livanova received a report stating that the tubing from the oxygenator outlet had disconnected.The issue occurred during procedure.The patient required blood transfusion.It was reported that the connection was tie-wrapped, as suggested in the instruction for use.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.The involved part was not made available for return.Based on all the gathered information, the most likely root cause of the reported tubing disconnection can be traced back to an alteration of the chemical mechanical characteristics of the tubings (which are supplied by a livanvoa supplier).The supplier has been formally informed of the event.No other specific action was currently deemed necessary.Livanova will maintain monitoring the market.H3 other text: device not available.

• Brand Name: SMARXT TUBING AND CONNECTORS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11306542
• MDR Text Key: 231126567
• Report Number: 1718850-2021-00024
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622136573
• UDI-Public: (01)00803622136573(240)627199102(17)210531(10)1913600048
• Combination Product (y/n): N
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 627199102
• Device Lot Number: 1913600048
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1