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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEMLIFE/CARDIAC ASSIST, INC. LIFESPARC PUMP SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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TANDEMLIFE/CARDIAC ASSIST, INC. LIFESPARC PUMP SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Lot Number 00870178
Device Problems Obstruction of Flow (2423); No Flow (2991)
Patient Problem Low Oxygen Saturation (2477)
Event Date 05/15/2020
Event Type  malfunction  
Event Description
Upon weaning from cardiopulmonary bypass, we transitioned to an oxygenated rvad for right heart support. The patient decompensated at 0626 and we converted back to cardiopulmonary bypass. Upon trying to recirculate the circuit, we were unable to achieve any flow. Once the pump head and circuit were drained, a sizable clot was present near the bearing inside the cone of the pump head. Fda safety report id #: (b)(4).
 
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Brand NameLIFESPARC PUMP SYSTEM
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TANDEMLIFE/CARDIAC ASSIST, INC.
MDR Report Key10100958
MDR Text Key193426495
Report NumberMW5094747
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number00870178
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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