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

Model Number 10-88-00

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).The pump was requested back to the manufacturer site for investigation but the reported issue could not be reproduced.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 mast roller pump shut off during procedure.After turning off and on the device, the pump was working without further issues.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: livanova deutschland received a report which was a duplicate of this specific case.Further evaluations allowed livanova deutschland to clarify the reported event.A field service technician was dispatched to the facility to investigate the device and found also that at low speeds the pump moved jerking but the reported shutdown could not be reproduced.Further investigation at the manufacturer site revealed black residues on the gap between pump head and shaft cage.A stuttering movement could be observed at lower speeds but the shutdown has not been reproduced.Also the pump control panel was requested by livanova deutschland in order to further investigate the event.During the investigation the display switch was found to be corroded and the insulation of the cable which links the pump to the display was found to be bent and partly damaged.The above mentioned parts were replaced.Functional verification testing was completed without further issues and the unit was returned to service.The stuttering movement identified by the field service representative on site and during the investigation performed at the manufacturer site may have led to the reported shut down of the pump.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

• Brand Name: S5 MAST ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 9087115
• MDR Text Key: 178153030
• Report Number: 9611109-2019-00729
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K062396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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: 10-88-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1