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

Catalog Number 5120-0000

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Livanova received a report through the theme clinical study that the flow of a tandemheart pump rapidly dropped during a procedure.The circuit was de-aired and the pump was connected to the patient.Flow was established without difficulty.An initial sweep gas flow of 100% oxygen at 3.3 lpm and 7500rpm was instituted.The flows then dropped to 1.7 lpm, then to 0.5 lpm.Volume resuscitation was performed, however flows did not improve.Eventually the circuit was clamped and disconnected and run in a saline bath with flows still around 0.5 lpm, leading user to determine the flow issue was related to the circuit.No clots were identified in the circuit.A full new circuit was connected and flow was re-established at 3.3 lpm.There was no report of patient injury as a result of the event.

Manufacturer Narrative

The initial report indicated that the patient was suffering from covid-19 and was on anticoagulants, which can contribute to clotting events.As the patient suffered from covid-19 and the event occurred more than 18 months prior to it being reported to livanova, the device was not made available for investigation.However, it is known that covid-19 disease can contribute/lead to clotting formation due to a higher incidence of coagulopathy and thrombosis.The decrease in circuit performance may have been due to accumulation of biological deposits within the pump leading to a reduction of flow through the device and consequently to a circuit exchange.Based on all available information, the most likely root cause of the reported event is patient-related.Based on the available information, a malfunction of the lifesparc pump could not be confirmed.Therefore, it cannot be ruled out that the issue was due to severe patient condition with the contribution of prolonged device usage.The serial number of the device was not provided, so a dhr review cannot be performed.As an exact root cause could not be determined, no specific corrective action has been identified.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.H3 other text : device not returned.

• 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: 15800879
• MDR Text Key: 307802684
• Report Number: 2531527-2022-00055
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue 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: 01/24/2023
• 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