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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
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
Customer informed me they experienced a level alarm that caused the arterial remote clamp to close and that caused a pump stop. Perfusionist 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 ((b)(4) : 60-01-35 that belongs to 60-00-60) and could not regain any flow with the centrifugal. She felt she "broke" the hand crank. She attempted to use another hand crank ((b)(4) : from the picture this is the 60-01-50 that belongs to 60-00-00 from the message from service rep it is another 60-01-35 from another s5 cp5 system) form a second pump and indicated she was unable to gain flow and felt she broke that handcrank 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. Sorin field service had been contacted and scheduled with the hospital to inspect the pump today, february 3. The circuit is available for return. Oxygenator from hl pack 044003500 / lot 16270000. Service confirmation results: service rep: i ran this unit for 2 1/2 hours and the machine has passed all functional tests and verifications. I 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. After verifying the function of the machine it was left in biomed. Cleaning out the alarm means that you try to overpass the pump stop (triggered by the level sensor) via control panel. (b)(6): this customer uses the revolution cp5 centrifugal pump and the erc electronic remote clamp. There was a clamping of the arterial line due to the level alarm. She reported that she attempted to ¿clear the alarm¿ by pressing the alarm clear button on the cdm (control desk module). It would not clear. It was at that time she turned off the level sensor module on the cdm. What does it mean ¿she turned off the level sensor¿ , do you mean that she used another one? (b)(6): no. Please see the response above for the answer to this question. Is the patient injured? (b)(6): from the event description i thought that the patient was stabilized. That status has been changed. In a direct call between myself and the risk manager she indicated that the patient had experienced ¿seizures¿ in the recovery unit. She indicated that the patient had previous (20 years prior) reports of epileptic seizures but had not experienced one in 20 years. How can it be that two emergency units were broken? the perfusionist must test the system before each surgery. I need to have pictures of these emergency units. (b)(6): i understand. In summary, the patient removed the arterial line from the erc yet could not gain forward flow with the cp5. The perfusionist used a cp5 handcrank to attempt to re-establish flow. The hand crank met significant resistance, could not regain flow, and ¿broke¿. The perfusionist feels she broke the drive mechanism from within the handcrank. After the handcrank breakage she attempted to utilize a second cp5 handcrank from a second s5 system they have in the operating room. This handcrank experienced the same breakage as the first. It was at this time that the perfusionist changed out the complete perfusion circuit and regained flow to the patient with the original s5 system. Which unit were they using? (s5 or s3)? s5. What kind of surgery were they performing? unknown. Two broken emergency unit - hand cranks? i need to understand this passage, this is highly improbable. Yes. Confirmed by field service technician over the phone. Were they using sorin (b)(4) oxy? yes, inspire 6s. Were they using sorin level pad? where did the perfusionist put the level pad? in which part of the oxy? yes. Unknown, unknown. Can i have pictures? pending. The perfusionist tried to clean out the level alarm which stopped the centrifugal pump but she did not succeed ergo she decided to turn off the level module in the e/p pack? is that right? i do not understand the statement ¿clean out the level alarm¿. The customer stated she experienced a level alarm with a full reservoir. She tried to clear the alarm and was not successful. She then turned the level sensor off. Can i have the read-outs of the pump used? the risk manager initially indicated that we would be provided the circuit and pump record. Once the patient was reported to be declining she indicated that their attorney was involved and we would have to wait to determine that status. It was said in an email that was received by myself and ray reid that they were going to identify an individual to be able to monitor the circuit evaluation. It was unclear, based in that email, if this person would want to participate with sorin in its evaluation. I need to have all the serial numbers of the s5 / s3; drive unit and level sensor. I have not been provided this information as of this time. Sorin field service representative, (b)(4), will be visiting the facility today to inspect the equipment. Perhaps (b)(6) can obtain some of this requested information for us. Hi (b)(4), i just followed reviewed this case with the hospital. The patient is still in care. The patient is still on a ventilator and responds to sound, but the level of permanent impairment cannot be determined at this time. This should be classified as a serious injury. The technician kept one of the broken cranks and left the other at the facility. I have sent an e-mail to the technician asking if the crank has been returned yet. The hlm was reviewed and found to be in working order. The unit was released back to service. I attached a copy of the tsi, which contains part and serial number information, to the complaint. I have also attached a copy. Thanks, (b)(6). (b)(4): 60-00-60 includes the following: cp5 drive unit 60-01-04, emergency drive unit with flexible shaft 60-01-35, pump control panel 60-02-60, flow sensor 3/8 96-414-140, flow module 25-60-70 (b)(4): 60-00-00 includes the following: scp drive unit 60-01-00, emergency drive unit without flexible shaft 60-01-50, scp control panel 60-02-15, flow sensor 96-414-120, c5 clamps are 60-05-60 and 60-05-65 , scp + scpc clamps are 60-05-00 and 60-05-40, c5 level sensor 23-27-40 - module 23-40-00. The disposable complaint is investigated under complaint number (b)(4).
Manufacturer Narrative
Livanova (b)(4) manufactures the cp5 emergency drive unit. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (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. A second hand crank was taken from another unit and the customer felt that this hand crank broke as well (see medwatch report 9611109-2017-00216 for details about second 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 hand crank was removed from service and taken by the service representative for further evaluation. 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, (b)(4) received a user medwatch report (mw5067832) related to this event. No additional information was included in the report.
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Manufacturer (Section D)
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer (Section G)
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
MDR Report Key6376483
MDR Text Key268478700
Report Number9611109-2017-00215
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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 Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-01-35
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/03/2017 Patient Sequence Number: 1