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

Model Number	48-40-00
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in usa.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that, during a procedure, the s5 erc tubing clamp malfuctioned.There is no report of any patient injury.
Additional Manufacturer Narrative
The s5 erc tubing clamp / 500mm was inspected as per cabling and function of cp5 rampdown/rampup tested level sensor, and calibrated: all tested within specifications.Unit placed back into service.Accordin to customet, the clamp closed during a case when the level alarm went off.It unlikely a training issue, it is more likely an intermittent issue.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
H10: a device service history review has been performed and identified that the unit was manufactured in 2022 and no other similar events have been reported.Based on the gathered elements, a clear root cause that led to the event cannot be identified.Nevertheless, based on investigation results of similar previous complaints and taking into consideration that the issue was not reproduced, it cannot be ruled out that one of the following factors may have contributed: an isolated event that caused the clamp not to operate as intended, an external event that caused the clamp to correctly close or open, differently from the user's expectation.
Event or Problem Description
See initial report.

• Brand Name: S5 ERC TUBING CLAMP / 500MM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18668133
• Report Number: 9611109-2024-00073
• Device Sequence Number: 8508687
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)220517
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2024

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 Model Number: 48-40-00
• Device Catalogue Number: 60-05-60
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 03/22/2024; 04/22/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/18/2024; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown