MAUDE Adverse Event Report: CARDIACASSIST INC. TANDEMHEART PUMP; NON-ROLLER TYPE BLOOD PUMP

Model Number 5120-0000

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/18/2020

Event Type  Injury  

Event Description

Livanova received a report that a patient experienced low flow during a case utilizing the tandemheart pump.The flow was initially at 4l however it dropped to about 1.7l when volume infusions were stopped.The user reported that the patient received a total of 4l of crystalloid during the event.Significant improvement in the flow was reported with volume resuscitation and administration of blood products.A heparin infusion was also performed.A couple days after the initial low flow event, the user noted oozing from the femoral cannula site which required intervention.Bleeding was also noted the following day on (b)(6) 2020, however this required no intervention.No further bleeding was noted after this date.

Manufacturer Narrative

Patient information was not provided.Serial number was not provided, so udi is not available.As the sn was not provided, the manufacturing date is unknown.Livanova manufactures the tandemheart pump.The reported event occurred in (b)(6) united states.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.Device not available for return.

Manufacturer Narrative

H.10.An investigation of the tandemheart pump could not be performed because it was discarded.The involved cannula, which is not a livanova product, was also discarded.Through detailed review of the theme registry entry, it was found that the patient had covid-19.Covid-19 disease can contribute/lead to clotting or bleeding formation due to a higher incidence of coagulopathy and thrombosis.A dhr review could not be performed because the serial number or lot number was not made available.A root cause for the bleeding could not be determined, as the device was not available for return.However, the bleeding was isolated to the cannula site, which was not a livanova device.Based on the information provided, there is no known malfunction of the tandemheart pump and the reported adverse event could not be linked to any livanova device.The pump appears to have functioned correctly without any reported issues.It can not be excluded that the reported bleeding was the result of the patient condition (covid-19 infection) and/or anticoagulation therapy.No corrective action was identified, as a root cause could not be determined.Livanova maintains and documents periodic customer event monitoring in order to evaluate actions for product improvement.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.

• Brand Name: TANDEMHEART PUMP
• Type of Device: NON-ROLLER TYPE BLOOD PUMP
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 15033628
• MDR Text Key: 296042933
• Report Number: 2531527-2022-00035
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5120-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other