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

Model Number 60-02-60

Device Problem No Flow (2991)

Patient Problems Death (1802); Coma (2417)

Event Date 07/01/2017

Event Type  Death  

Manufacturer Narrative

(b)(6).Livanova (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).Through follow-up communication, livanova (b)(4) learned that the device was quarantined by the facility.A livanova field service representative was dispatched to the facility to investigate.The service representative reported that the unit did not display any alarm or error messages during the event.The device is currently at the hospital awaiting internal investigation.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.Device not returned.

Event Description

Livanova (b)(4) received a report that the centrifugal pump 5 (cp5) failed during a procedure.The patient underwent an aortic valve replacement procedure on (b)(6) 2017 and developed post operative tamponade on (b)(6) 2017.Emergency open internal cardiac massage was performed and the patient was transferred to the operating room for surgery.During set-up, the user noticed that the control panel display registered 15.8 l/min at 1200 rpm.The flow probe was disconnected and reattached to the arterial line and the display showed no flow.The user attempted to pump fluid to the aortic line and found that the fluid was not moving.The cp5 was exchanged for an alternate unit and the procedure continued without further incident.Patient care was delayed approximately 10 minutes.The patient is in a coma.

Manufacturer Narrative

Livanova (b)(4) was informed on august 21, 2017 that the patient had passed away.Due to the patient death, the type of reportable event was updated from "serious injury" to "death." the device was returned to livanova (b)(4) for further investigation.During intensive stress testing with excessive temperatures, the flow board failed and the reported failure was reproduced.The flow board was returned to the supplier for investigation and it was discovered that a loose connection under a surface mounted device on the flow board caused the reported issue.It was not possible to determine how this connection became loose.The manufacturer stated that the complained board passed all final tests after assembly.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• 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: 6752167
• MDR Text Key: 81361939
• Report Number: 9611109-2017-00584
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• 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
• Patient Outcome(s): Death; Other
• Patient Age: 72 YR
• Patient Weight: 58