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

Model Number 48-40-00

Device Problem Device Alarm System (1012)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not duplicate the issue.As a precaution it has decided to change out the cp5 control panel sn# (b)(4) and replaced it with a reconditioned cp5 sn# (b)(4) also replaced the centrifugal drive motor sn# (b)(4) with reconditioned centrifugal drive motor sn# (b)(4).All components have been inspected and tested according to the manufacturers specifications.All tested to be ok.In case of additional information a follow-up report will be provided.

Event Description

Livanova received a report about a cp5 control panel giving time-out alarm and then it turned out by itself.No patient involvement reported.

Event Description

See initial report.

Manufacturer Narrative

H.10: the most likely root cause of the reported issue is a controller area network (can) interruption due to a defective hkr board located in the cp5 control panel.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 12377149
• MDR Text Key: 268455977
• Report Number: 9611109-2021-00480
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900894
• UDI-Public: 010403381790089411201009
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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: 48-40-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1