MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-85-00

Device Problem Pumping Stopped (1503)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 double head pump.The incident occurred in hamburg, germany.Through follow-up communication livanova learned that the user turned up the pump during priming and the error occurred, leading to a pump stop.Livanova initiated an investigation.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 double head pump gave a motor control failure error message during priming.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

No further complaints have been reported since the unit was put back in service.Complaints database analysis revealed no similar event since unit installation in 2005.Based on the above, the root cause of the reported failure can be addressed by a defective hkr board.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event, however there is no concerning trend for this kind of failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Manufacturer Narrative

The device was returned to manufacturer for investigation and complained error was confirmed (without tubing inserts).Sings of wearing were identified.Pump was then cleaned, computer board (hkr board) and base plate were replaced.The device was tested and returend successfully to customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See intial report.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17037011
• MDR Text Key: 316606771
• Report Number: 9611109-2023-00246
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2005
• 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