MAUDE Adverse Event Report: CARDIACASSIST INC. SHIP KIT, PUMP, TANDEMHEART PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 5120-0000

Device Problem Failure to Pump (1502)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided, and patient outcome is unknown.Cardiacassist inc.Manufactures the tandemheart pump.The incident occurred in the united states, though the the exact location and hospital is unknown, as it was not included in the elso clinical report.As no details regarding the hospital, device or nature of the pump failure were included in the clinical report, additional investigation is not possible at this time.Due to elso confidentiality agreements with hospitals and livanova, it is not expected that further information will be provided on these incidents.However; if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Received an elso clinical report detailing observed outcomes in a number of patients who utilized the tandemheart pump during treatment.This included a reported tandemheart pump failure.The exact nature of the pump failure and impact on the patient were not detailed in the clinical reports.No details about the hospital(s), patient(s) or specific pump(s) were provided in any of the clinical reports.

• Brand Name: SHIP KIT, PUMP, TANDEMHEART PUMP
• Type of Device: 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: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 14518024
• MDR Text Key: 300445985
• Report Number: 2531527-2022-00029
• 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: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5120-0000
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1