MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ERC TUBING CLAMP / 500MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-60

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 erc tubing clamp / 500mm.The incident occurred in pittsburg, pennsylvania.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The hospital has trained biomeds and services its own equipment.A replacement device was provided.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a s5 erc tubing clamp / 500mm was not working properly and displayed an error message during procedure.Reportedly, the clamp was sluggish when opening and closing and the user replaced device with a backup one but the same error occurred.The user decided to use again the original clamp and error no longer reoccurred.After the procedure the clamp was checked again and the error was still there.There was no report of patient injury.

Manufacturer Narrative

H.10: the affected device was received to the manufacturer site for investigation.A calibration failure error message was displayed which disappeared after turning off/on three times indicating a reboot of internal firmware.No further deviation could be reproduced during functional tests.The clamp board will be replaced as potentially involved.

Event Description

See initial report.

• Brand Name: S5 ERC TUBING CLAMP / 500MM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10928076
• MDR Text Key: 218956985
• Report Number: 9611109-2020-00663
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• 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: 11/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 60-05-60
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1