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

Model Number 5800-0000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bradycardia (1751)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

There was no patient involvement.Cardiacassist inc.Manufactures the lifesparc system.The incident occurred in (b)(4).Investigation is ongoing.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 during the addition of crrt/cvvh to the lifesparc system, air was entrained and passed to the patient which became bradycardiac and lost consciousness after stating he did not feel well.Heart rate went from 100 to 30, flows dropped from 4 to 2 lpm.Reportedly, the air appeared to have been introduced through the crrt/cvvh machine and not the lifesparc pump.After some time flow increased back to 4 lpm.The customer exchanged the lifesparc pump with a cardio help system.Reportedly, the patient is doing well.

• Brand Name: LIFESPARC
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh 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: 10553453
• MDR Text Key: 207526198
• Report Number: 2531527-2020-00029
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183623
• 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
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5800-0000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2020
• 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