MAUDE Adverse Event Report: CARDIACASSIST INC. LIFESPARC SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number	5800-0000
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that during patient support with a lifesparc pump, low flow was noted and the system correctly alarmed for low flow.Reportedly, flow decreased from 3.5 lpm to 0.5 lpm.The pump was changed out and the issue could be solved.There was no report of patient injury.
Additional Manufacturer Narrative
There was no patient involvement.Cardiacassist inc.Manufactures the lifesparc system.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.It was reported that the pump was used in combination witha quadrox oxygenator (not manufactured by livanova).All tubings and the oxygenator were discarded.Through follow-up communication livanova learned that medical staff did not notice any signs of blood clots.A livanova representative examinated the circuit and noticed some white patches in the tubings.A video confirming the presence of the white patches was provided.It is unclear if these patches had caused the low flow issue.In addition, it was reported that the hospital uses partial thromboplastin time (ptt) to treat anticoagulation.The ptt value at the time of failure was 85.6.Therapeutic goals for this account is a ptt between 60-80.Device instruction for use provides indications regarding the monitoring of activated clotting time (act) along the support and no indication regarding ptt is prescribed.The affected pump was requested for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Udi code added in dedicated d.4.Section.H.10: the device was returned to the manufacturer site for investigation.A functional test to in-process assembly specifications could not be completed since the pump was not able to be started.Visual inspection revealed large masses of biological material throughout the pump blood chamber and tubing, including in the pivot bearing region and secondary flow path.After visual inspection, an axial load measurement revealed pump magnetic offset to be within specifications.The assembly showed no signs of mechanical wearing or failure in the pivot bearing area or on the impeller blades.Finally, it was determined from the controller logs that the pump flows eventually continued to decrease towards no flow across the four-hour duration with similar current and speed trends.The patient was anticoagulated within the hospital requirement for use of the lifesparc pump (ptt measured 85.6, hospital requirement between 60-80), but no act readings were reported.The lifesparc pump dfu (cr-pit-2019-0110) states, ¿during support, the patient¿s activated clotting time (act) should be maintained at approximately 200 seconds to help control the formation of thrombus." based on gathered information and on investigation results, it cannot be ruled out that the pump, operating normally, faced increasing resistance from the overall ecmo circuit, patient inflammatory response, and anticoagulation strategy during this case.

• Brand Name: LIFESPARC SYSTEM
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 13393111
• Report Number: 2531527-2022-00005
• Device Sequence Number: 11736230
• Product Code: KFM
• UDI-Device Identifier: 00814112020609
• UDI-Public: (01)00814112020609(11)210927
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K183623
• 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): 01/31/2022

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: 5800-0000
• Device Catalogue Number: 5800-0000
• 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: 01/02/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown