Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN SORIN - LIVANOVA; HEATER-COOLER
  • 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
 

SORIN SORIN - LIVANOVA; HEATER-COOLER Back to Search Results
Model Number 3T
Device Problems Product Quality Problem (1506); Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 04/18/2017
Event Type  Injury  
Event Description
A (b)(6) male with a history of idiopathic cardiomyopathy s/p heart transplant (b)(6) 2012 with failure to thrive and weight loss.Found to have rul three in bud nodules and afb culture positive mycobacterium chimaera (b)(6) 2017.We are evaluating if this is related to the known issue with heater cooler devices.Pt started on therapy with azithromycin, ethambutol and rifabutin (b)(6) 2017.The isolate has been sent to (b)(6) for whole genome sequencing to see if related to the known mycobacterium chimaera infections associated with (b)(4) stockert 3t heater-cooler systems as outline in fda safety communications.We expect results in several weeks.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SORIN - LIVANOVA
Type of Device
HEATER-COOLER
Manufacturer (Section D)
SORIN
lindberghstrasse 25
munich 80939
GM  80939
MDR Report Key6563328
MDR Text Key75151254
Report Number6563328
Device Sequence Number1
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/01/2017
Distributor Facility Aware Date04/18/2017
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer05/01/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
HEART-LUNG MACHINE (B)(4)
Patient Outcome(s) Life Threatening;
Patient Age68 YR
Patient Weight84
-
-