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

Model Number 10-80-00

Device Problem Pumping Problem (3016)

Patient Problem Hemolysis (1886)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility and checked the pump and it was found to be within specifications.Investigation is still ongoing in order to clarify if the pump is involved in the reported event.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 report that hemolysis problem was noticed during procedures.Reportedly, six (6) patients had haemolysis and at least 2 of them had benefit from dialysis.A s5 roller pump was used.The pump has been removed from service.

Event Description

See initial report.

Manufacturer Narrative

Review of the dhr could not identify any deviations or nonconformities relevant to the issue.The pump was returned to livanova and it has been investigated.As result of investigation the pump occlusion and eccentricity values were found to be within specification.Haemolysis test was performed simulating worst case conditions for haemolysis formation by comparing the complained pump with other similar devices.Based on investigation results, the claimed pump conforms to the approved functional specification for occlusion and concentricity.No impact on pump safety and performance has been observed during the test.Therefore, a pump malfunction can be excluded.Consequently, there is no likelyhood for this device to contribute to death or serious injury.The involvement of the device in the reported event can be ruled out thus the event has been reassessed as non-reportable.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10312103
• MDR Text Key: 201890590
• Report Number: 9611109-2020-00438
• Device Sequence Number: 1
• Product Code: DWB
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1