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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 Problem Improper Flow or Infusion (2954)
Patient Problem Inflammation (1932)
Event Date 08/06/2021
Event Type  Injury  
Manufacturer Narrative
There was no patient involvement. 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.
 
Event Description
Livanova received report that tandemlung oxygenator (originally placed on (b)(6) 2021) was changed out due to co2 removal decrease. After replacement, the patient developed a sirs response with anemia due to volume loss with oxygenator exchange. Transfusion was given and bp was increased with neo. There was no report of patient injury.
 
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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 15238
MDR Report Key12428296
MDR Text Key272542595
Report Number2531527-2021-00034
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,Followup
Report Date 09/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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
Event Location No Information
Date Manufacturer Received10/04/2021
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: 09/06/2021 Patient Sequence Number: 1
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