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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 5160-0000
Device Problem Decrease in Pressure (1490)
Patient Problem Low Oxygen Saturation (2477)
Event Date 06/12/2020
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 united states. 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 (b)(4) received a report that a (b)(6) year old male patient with acute respiratory failure from covid-19 pneumonia was placed on vv-ecmo support with the tandemheart pump and tandemlung oxygenator on (b)(6) 2020. After 10 days, post oxygenator blood gas showed a low value for pao2 (80) and the oxygenator became hazy. Reportedly, a clotting was possible. The oxygenator was exchanged and the blood pressure dropped immediately thus, medication (phenylephrine) was administered. The tandemheart device was removed (b)(6) 2020 without further need for support and the subject was discharged from the hospital on (b)(6) 2020 to an extended care facility.
 
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Brand NameTANDEMLUNG OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10688680
MDR Text Key211654101
Report Number2531527-2020-00034
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
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5160-0000
Device Catalogue Number5160-0000
Device Lot NumberUNKNOWN
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 Received09/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/16/2020 Patient Sequence Number: 1
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