MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CP5 EMERGENCY DRIVE UNIT; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-01-35

Device Problems Device Operational Issue (2914); Physical Property Issue (3008)

Patient Problems Seizures (2063); Ventilator Dependent (2395); Patient Problem/Medical Problem (2688)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Livanova (b)(4) manufactures the cp5 emergency drive unit.The incident occurred in (b)(6).(b)(4).A livanova field service representative was dispatched to the facility to investigate.The customer informed the representative that significant resistance was felt when the hand crank was used and the user could not regain flow.The user felt the drive mechanism within the hand crank had broken.This was the second hand crank to experience this issue during this procedure (see medwatch report 9611109-2017-00215 for details on the first hand crank).In order to reestablish flow, the entire disposable circuit was replaced.The customer reported that the patient was responsive in the recovery unit following the procedure.The service representative inspected the hand crank and confirmed that it was broken.The customer elected to keep the hand crank.Through follow-up communication with the customer, livanova (b)(4) learned that the patient experienced seizures following the procedure.The customer stated that the patient has experienced epileptic seizures in the past, but not for about 20 years.The latest information from the facility is that the patient is still on a ventilator and responds to sound.The level of permanent impairment has not yet been determined.The investigation is on-going.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 the customer broke the hand crank of the cp5 emergency drive unit during an attempt to reestablish flow following a centrifugal pump stop (pump stop reported on medwatch report 9611109-2017-00131).The facility reported that the patient was off pump for 10-15 minutes during this event and had to be placed on a ventilator following the procedure.

Manufacturer Narrative

Initial reporter also sent report to fda: yes.On march 3, 2017, livanova (b)(4) received a user medwatch report (mw5067832) related to this event.No additional information was included in the report.

Manufacturer Narrative

A livanova field service representative ran the unit for 2 1/2 hours and the machine has passed all functional tests and verifications.He was able to get the original level sensor strip to test it on the machine.The level sensor did have a bent prong.The prong that normally sticks through the sensor strip was pushed back and folded between the adhesive backing and the back portion of the sensor strip.This did not allow for proper connection to the level sensor probe.The hand crank was returned for analysis.Livanova usa performed an in house investigation with the following results.Reports of the hand crank/cp5 emergency drive unit were confirmed as the broken drive shaft would not drive the revolution pump to create flow.The narrowing of the drive shaft at the break point indicates that the shaft was able to rotate before the bend, but not beyond the bend.This scenario caused the drive shaft windings to twist and tighten to the breaking point of the windings and the drive shaft core.The root cause for the bend remains unknown.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Event Description

Livanova (b)(4) received a complaint regarding a level alarm that caused the arterial remote clamp to close and that caused a pump stop.The customer indicated there was not a low level alarm state and that the alarm should not have occurred.She pressed the clear button with no success in clearing the level alarm and resuming flow.She then turned off the level alarm module.She could not regain flow.She removed the arterial line from the arterial line clamp and still could not regain flow (the perfusionist thought that the closed-clamp could have been the reason why she did not regain flow, so she opened it but still the flow was not running).She attempted to utilize the cp5 hand crank and could not regain any flow with the centrifugal.She felt she "broke" the hand crank.She attempted to use another hand crank from a second pump and indicated she was unable to gain flow and felt she broke that hand crank as well.She then changed out the entire circuit and was able to regain flow to the patient.She indicated the patient was off pump for 10-15 minutes.She informed me they were cross-clamped and the heart was stopped.The patient was fully cooled.They used ice to pack around the patients head.After these 15 minutes the cardiac surgery team replaced the disposables (tubing / reservoir) and the level sensor but they used the same console to finish the operation.After the replacement, the units of the console were perfectly working.The patient's heart surgery was completed.The patient left the room.She indicated that the patient was responsive in the recovery unit.

• Brand Name: CP5 EMERGENCY DRIVE UNIT
• 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: 6376470
• MDR Text Key: 69014593
• Report Number: 9611109-2017-00216
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-35
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• 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): Hospitalization; Life Threatening; Other
• Patient Weight: 74