MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-60

Device Problem Unexpected Shutdown (4019)

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

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).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 (b)(4) received a report that a centrifugal pump 5 (cp5) display spontaneously switched off during priming.The screen went black and the control panel began to alarm.The switch behind the pump was switched off and on a couple times but it would not power-on.The hlm was then switched off and on at the base, at which point the arterial pump monitor began working again.The user decided to replace the cp5 panel with another.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

Udi code has been added to the dedicated d.4 section.Manufacturing date of device has been corrected since the one provided in the initial report was reported incorrectly due to a mistake.H.10: the involved cp5 was manufactured in 2017 and according to the analysis of the complaints database no similar events related to this unit have been reported in the past.The cp5 control panel was returned to the manufacturer site for investigation.No malfunctions of the cp5 control panel was observed during the intensive test and the unit worked within specifications.Based on the above facts and on the investigation performed for similar cases, it cannot be ruled out that an intermittent issue of the processor board of the cp5 control panel could have led to the reported event.

Manufacturer Narrative

H.10: further tests were performed, during repair at the manufacturer site.And the reported issue could not be reproduced.The switch of the control panel was replaced.As per, equipment maintenance intervention prevention.Subsequent, functional verification testing was completed without further issues.And the unit was returned to service.It cannot be ruled out, that an intermittent issue with the switch of the cp5 control panel.Most likely, due to oxidation in the switch contacts, could have led to the reported event.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13088903
• MDR Text Key: 285387689
• Report Number: 9611109-2021-00733
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)171130
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112225
• 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: 12/27/2021

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: 60-02-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 05/10/2022; 08/02/2022
• Supplement Dates FDA Received: 05/20/2022; 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• 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