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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVA NOVA SORIN / LIVA NOVA USA, INC. LIVA NOVA SORIN 6F INSPIRE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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LIVA NOVA SORIN / LIVA NOVA USA, INC. LIVA NOVA SORIN 6F INSPIRE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number REF # 044003200
Device Problems Contamination (1120); Fluid Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 08/08/2019
Event Type  Injury  
Event Description
Fluid was seen leaking out of the sorin inspire 6f oxygenator temperature port during priming. It was changed out and reported to the company. Thankfully it was noticed before cpb was initiated. Recently, among a discussion with colleagues this is a common serious problem (12+ cases at least) and blood leaks out of the port during the cpb run and a serious sterility and cross contamination issue as the temp probe is reused and put into the temperature prob port with the leak. Fda safety report id # (b)(4).
 
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Brand NameLIVA NOVA SORIN 6F INSPIRE OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVA NOVA SORIN / LIVA NOVA USA, INC.
MDR Report Key9805331
MDR Text Key182922312
Report NumberMW5093618
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF # 044003200
Device Lot Number1912700021
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/06/2020 Patient Sequence Number: 1
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