• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDIACASSIST INC. TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 5160-0000
Device Problem Decrease in Pressure (1490)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
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 for tandemlung did not identify any deviations or non-conformities relevant to the reported issue. Through follow-up communication livanova learned that no cracks/fractures were noted on the oxygenator. 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 a tandemlung oxygenator was not working as soon as the support was started. There was a little gas exchange and the po2 decreased from 55 to 50. The circuit was exchanged. There was no report of patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTANDEMLUNG OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIACASSIST INC.
620 alpha drive
pittsburgh 15238
Manufacturer (Section G)
CARDIACASSIST.INC
620 alpha drive
pittsburg PA 15238
Manufacturer Contact
enrico greco
620 alpha drive
pittsburg, PA 15238
MDR Report Key11054105
MDR Text Key265605990
Report Number2531527-2020-00036
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 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
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 Received01/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-