MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	60-02-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).Based on current level of information, the reported adverse event was solely due to an user error in powering off the centrifugal pump and is not related to any device malfunction.In addition, based on provided information, it is very likely that the patient lost consciousness due to the kink of cannula impacting return flows and not to the power off of the pump which reportedly was immediately turned back on by the user.A review of complaints database revealed that no further events of users accidentally switching off the centrifugal pump system have been reported so far, indicating that there is no trend or pattern for this type of event and that there is no relationship between the reported incident and livanova equipment.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.No service request received from the customer.Device did not malfunction.
Event or Problem Description
Livanova received a medwatch report mw5106649 stating that the np had his hand on the scp centrifugal pump and inadvertently flipped the power switch to off.The pump was immediately turned back on but the patient began immediately to lose consciousness.Reportedly the pump was then moved to hand crank to restore flows since the patient had slouched down and his return cannula was kinked off which delayed the flows.Once the kink was fixed, the flows were restored and the patient regained consciousness.The patient did not require cpr and had no recollection of the event.It was reported that the switch of the scp centrifugal pump was taped to the on position with a tongue depressor.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindbergstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13657920
• Report Number: 9611109-2022-00096
• Device Sequence Number: 5170458
• Product Code: DWA
• UDI-Device Identifier: 04033817900986
• UDI-Public: (01)04033817900986(11)160311
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K032213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60-02-15
• 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: 03/02/2022
• Initial Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown