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U.S. Department of Health and Human Services

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

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CARDIACASSIST INC. TANDEMLUNG OXYGENATORS OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 5160-0000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemolysis (1886); Thrombocytopenia (4431)
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Cardiacassist inc. Manufactures the tandemlung oxygenator. The incident occurred in (b)(6). Based on the information currently available, a medical assessment was requested revealing that the reported hemolysis is not related to tandemlung oxygenator and that it is a risk associated to the procedure itself. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device in use.
 
Event Description
Livanova received report that during ecmo support of a covid-19 patient a dual tandemlung oxygenators setup was used and hemolysis associated with anemia requiring rbc transfusion was noticed on (b)(6) 2021. Due to significant hemolysis noted and thrombocytopenia, the flow was minimized maintaining adequate global perfusion. The patient has been off heparin infusion for roughly 24 hours and reportedly there is a plan to restart heparin infusion for or possible clots formation.
 
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Brand NameTANDEMLUNG OXYGENATORS
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 15238
MDR Report Key12506083
MDR Text Key275161075
Report Number2531527-2021-00041
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 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
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 Received10/21/2021
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: 09/21/2021 Patient Sequence Number: 1
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