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

Model Number 10-85-00

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.He adjusted the knob and the issue was solved.Functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 double head pump speed control knob was loose after the procedure.There was no report of patient injury.

Manufacturer Narrative

H.10: an increasing trend has been identified for loose shaft encoder issue on centrifugal pump 5 (cp5).This triggered a detailed investigation which revealed that in case of loose shaft encoder on cp5 system the control of the pump speed is not impacted.Indeed, the shaft angle encoder movements are limited by mechanical constraint of the housing/circuit boards.A loose shaft encoder will only result in less than 0,5 seconds of unresponsiveness which is the time needed by the encoder to reach the housing.Thus, the pump speed can still be controlled by the user through the knob.Based on the above the reported event has been re-assessed as non reportable.

Event Description

See initial report.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9467468
• MDR Text Key: 194320879
• Report Number: 9611109-2019-00968
• 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: 12/13/2019

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: 10-85-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1