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

Model Number 5120-0000

Device Problem Obstruction of Flow (2423)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Cardiacassist inc.Manufactures the tandemheart pump.The incident occurred in (b)(6).A review of the dhr did not identify and deviations or non-conformities related to the reported issue.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a tandemheart pump malfunctioned during support.The pump was originally placed on (b)(6) 2021.Reportedly, the issue was likely caused by thrombus.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

The failure occurred after 14 days of support on covid-19 patient.Covid-19 disease can contribute/lead to clotting formation due to a higher incidence of coagulopathy, resulting in pump obstruction.Consequently, taking also into account that pump and relative circuit worked properly for 14 days, the most likely root cause of the reported event is patient related and device malfunction can be excluded.

• 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: enrico greco ; 620 alpha drive; pittsburgh, PA 80004
• MDR Report Key: 12432578
• MDR Text Key: 270576305
• Report Number: 2531527-2021-00035
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5120-0000
• Device Catalogue Number: 5120-0000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1