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

Model Number 60-05-65

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 erc tubing clamp / 620mm.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device.The clamp was functional but noisily.The device will be returned to the manufacturer site for further investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a s5 erc tubing clamp / 620mm was stuck during priming and displayed error codes.The user did not remember which error codes had appeared.There was no patient involvement.

Manufacturer Narrative

H.10: the device was returned to the manufacturer site and the reported failure was confirmed.Several parts were replaced to solve the issue and the unit was then shipped back to the customer.Based on the investigation performed for similar cases, the most likely root cause of the reported event is assigned to fluid ingress and use conditions (i.E.Extensive exposure to liquid, e.G.During cleaning).

Event Description

See initial report.

• Brand Name: S5 ERC TUBING CLAMP / 620MM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11019105
• MDR Text Key: 221825715
• Report Number: 9611109-2020-00685
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1