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

Model Number	60-01-04
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received report that about after 20 minutes from procedure started, there was no flow despite rpm of the centifugal pump 5 (cp5) being 3800.Flow was down and there was negative line pressure.The original thought was a pressure excursion which could be excluded by user because as they hand cranked everything flowed.The vacuum was removed and the cannula was verified not to be occluded.The user turned the cp5 off and back on while continuing to hand crank and the problem persisted.The user turned the device off and back on again and this time everything went back to normal and hand crank was stopped.The procedure could be completed with no further issues.Reportedly, there were no alarms or error messages.There was no patient injury.
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: through follow-up communication livanova learned that differently from what stated in b5 section of the initial report "the user turned the cp5 off and back on while continuing to hand crank and the problem persisted.", the user did not turn off the device the first time but only the speed control knob was set to zero rpm while performing hand crank.The issue, as reported in b.5 section of the initial report, could be solved afterwards when the vacuum was off and by turning the pump off and back on.Based on additional information provided, the reported no flow issue was not related to any device malfunction and could be traced back to configuration applied by the user during surgery, in detail the vacuum used in combination with a non obstructive pump generating a negative pressure in the reservoir higher than pressure created by revolution pump and consequently leading to no forward flow.This scenario is compatible with all information provided by the customer.Indeed, the issue could be resolved once the vacuum was de-activated, the pump turned off and back on allowing the reset of the previous pressure control condition and then device could be used to complete the procedure.Considering the available information, the reportability decision changes to not reportable event since the reported issue was related to configuration technique and not related to device failure.
Event or Problem Description
See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Common Device Name: 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: 15697993
• Report Number: 9611109-2022-00553
• Device Sequence Number: 20209009
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)191211
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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
• Operator of Device: Health Professional
• Device Model Number: 60-01-04
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown