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

Model Number 60-02-60

Device Problem Pumping Stopped (1503)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

Livanova received report that a centrifugal pump cp5 turned off by itself during procedure, the screen became black and the drive unit stopped).The user waited 3 seconds but the cp5 did not work, so the device was turned off and back on.The cp5 and drive unit continued working fine during the rest of the surgery and it was used also the next day without problems.There was no patient injury.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in panama, panama.A livanova field service representative was dispatched to the facility and could not reproduce any error message.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the issue never recurred since the day of the event.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Read out analysis revealed that the error code index_impulse_missing was stored during the day of the event."index impulse missing" error was most likely caused by the user disconnecting the drive unit cable from the panel while the panel was still powered on.This stored code is not compatible with the reported cp5 panel switch off and it is unrelated to the reported malfunction.During the day of the event the code timeout_intervention 0006h was also stored in the microcontroller.This code indicates a deactivated bubble monitoring function and it does not lead to the cp5 panel switch off.Also this stored code is therefore unrelated to the reported malfunction.Thus, no hardware / software malfunction possibly leading to the reported event are stored in the cp5 panel read-out during the day of the event.Based on available information and service activity, the reported event was most likely caused by an intermittent communication between the cp5 control panel and the s5 ep/pack, leading to the cp5 black out and to the subsequent drive unit stop.It cannot be ruled out that the intermittent communication was due to a not properly connected cp5 panel to the ep pack or to an accidentally bumped on/off switch of the cp5 panel by the user.

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: 15174222
• MDR Text Key: 297899450
• Report Number: 9611109-2022-00395
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)190812
• Combination Product (y/n): N
• Reporter Country Code: PM
• 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: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• 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
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• 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