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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 Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Cardiacassist inc. Manufactures the tandemlung oxygenator. The incident occurred in (b)(6). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Livanova initiated an investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Type of investigation not yet determined.
 
Event Description
Livanova received report that a tandemlung oxygenator was changed out during vv ecmo support due to arterial blood gas results showing oxygen saturation 68%. After oxygenator replacement which occurred one day of support, the oxygen delivery was reportedly adequate. 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 Key11967150
MDR Text Key265836968
Report Number2531527-2021-00022
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 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
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
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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