MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 C(P5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-60

Device Problem Alarm Not Visible (1022)

Patient Problem No Patient Involvement (2645)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

This report was originally filed on august 22, 2017.However, due to an error with the phone number formatting, the report was not successfully submitted.The phone number has been corrected and the report is being resubmitted on august 28, 2017.There was no patient involvement.Though a serial number is provided, the reported issue is a more general complaint regarding this type of device.(b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The reported case was reviewed by livanova (b)(4) r&d and qa investigators.The pressure module is designed for the use with a roller pump and a centrifugal pump system.To avoid fluctuating pressure values on the display caused by the roller pump, the pressure values are averaged.The measured pressure is averaged for a duration of 1 second to trigger a system reaction (e.G.Ramp down function, if adjusted on the system).The measured pressure is averaged for a duration of 3 seconds to trigger an alarm displayed by the system.The default reactivity of the cp5 in the case that the predefined pressure limit is reached is for the pump speed to decrease until the pressure drops below the limit.If the predefined negative flow limit is reached, the erc (electrical remote-controlled tubing clamp) closes automatically.The erc does not automatically open and can only be opened by the user.Once the pressure alarm disappears and the clamp is open the pump speed increases automatically up to its former value.The use of this ramp down function in response to an over-pressurization is optional.The activation of the optional ramp down function in response to an over-pressurization enables the pump speed to quickly decrease to the predefined minimum value and the system will behave as it does in its default state.The minimum pump speed is set to 1000 rpm by default.This value can be adjusted by the perfusionist and should be adjusted based on the device arrangement for a given procedure in order to prevent a negative flow.After reviewing the case, livanova (b)(4) has concluded that no deviation from the specifications have occurred.Between january 2014 and july 2017, (b)(4) cp5 devices have been sold worldwide and livanova (b)(4) has received no indication that the use of a ramp down function in response to an over-pressure has led to a critical situation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Issue not related to a specific device.

Event Description

Livanova (b)(4) received a report that a perfusionist is concerned regarding normal operation of the centrifugal pump 5 (cp5) in a situation where the pressure spikes above the pre-defined pressure limit and triggers a pump speed ramp down (when the ramp down function is active) to the predefined minimum speed, which then triggers a negative flow alarm.Only the negative flow alarm is displayed and not the pressure alarm.This scenario has occurred in the past during a procedure leading to patient death (see medwatch report 9611109-2016-00499).This medwatch report is related to the of the perfusionist to reproduce the described scenario.There is no patient involvement.

• Brand Name: CENTRIFUGAL PUMP 5 C(P5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6824767
• MDR Text Key: 83856195
• Report Number: 9611109-2017-00671
• Device Sequence Number: 1
• Product Code: DWA
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/28/2017

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?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• 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