MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ERC TUBING CLAMP / 620MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-65

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 erc tubing clamp / 620mm.The incident occurred in (b)(6).The device was returned to livanova (b)(4) for further investigation.During the evaluation the reported issue could not be confirmed.The device worked according the specification.As the issue could not be reproduced or confirmed, a root cause was not identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Event Description

Livanova received a report that a s5 erc tubing clamp / 620mm shut off during procedure.There was no report of patient injury.

• Brand Name: S5 ERC TUBING CLAMP / 620MM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: dominik wagner ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 8729965
• MDR Text Key: 149093486
• Report Number: 9611109-2019-00475
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817901068
• UDI-Public: (01)04033817901068(11)151029
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071318
• 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
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-05-65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1