MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-45

Device Problem Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).The failure was traced back to a circuit board short-circuit.Investigation is ongoing.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 of a s5 gas blender system short-circuit during procedure.There was no report of patient injury.

Manufacturer Narrative

H.10: the affected device was returned to the manufacturer site for repair.The reported issue could be confirmed upon testing.In addition, a deviation with the mass flow controller for o2 could be identified and an error code associated to set/actual value comparison was displayed during pre-calibration phase.To solve the reported issue the dc-supply board shall be replaced.The measuring bridge, the mass flow controller for o2 and for air shall be replaced as well.Due to high repair costs, it is likely that the customer will decide to scrap the device.The root cause of the reported short-circuit was a defective dc-supply board.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: repair quotation was rejected by the customer because the customer bought a new device.Thus, the device will not be repaired and has been shipped back to the customer unassembled and marked "not for clinical use".

Event Description

See initial report.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich, germany 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 12589291
• MDR Text Key: 275197252
• Report Number: 9611109-2021-00563
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2021

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: 25-40-45
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 11/15/2021; 02/26/2022
• Supplement Dates FDA Received: 12/02/2021; 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2007
• 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