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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIACASSIST INC. TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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CARDIACASSIST INC. TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 5160-0000
Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemolysis (1886); Thrombosis/Thrombus (4440)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. Cardiacassist inc. Manufactures the tandemlung oxygenator. The incident occurred in (b)(6). Livanova initiated an investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Clinical study-device not available.
 
Event Description
Livanova received a report that during patient support with a tandemlung oxygenator, on (b)(6) 2021 red cell lysis was observed as well as a decrease in po2 to 110. Reportedly clots were also noticed from (b)(6). It was decided to replace the oxygenator.
 
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Brand NameTANDEMLUNG OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
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 Key12632664
MDR Text Key276403346
Report Number2531527-2021-00043
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153295
Number of Events Reported1
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 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5160-0000
Device Catalogue Number5160-0000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/14/2021 Patient Sequence Number: 1
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