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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided. Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). A complaints database analysis revealed that no previous device contamination complaints were submitted by this hospital. A service history review did not identify any deviations or non-conformities relevant to the reported issue as well as dhr review. Since no contamination cases have been received from this hospital in the past the cleaning practice in place back in the 2017 for heater-cooler devices are still unknown as well as the current practice. Livanova will attempt to retrieve additional information to clarify the reported event. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova received a medwatch report (b)(4) that a (b)(6) years old patient undergone a cardiac surgery in the early 2017 for mitral valve replacement. The patient has been recently admitted to the hospital with worsening pain to his bilateral lower extremities, numbness in his anterior and lateral thighs and difficulties with urination. The patient underwent magnetic resonance which was noticable for a slight increase of t 3-4 and l 4-5 abscesses. Nearly a week later, the patient underwent a multi-level laminactomy and fusion for abscesses drainage. A would culture was sent on that day and processed in a reference lab and came back positive to m. Chimaera. Reportedly, a heater-cooler system 3t was in use at the time of the surgery back in early 2017 and the patient will require prolonged treatment for m. Chimaera infection. The patient was discharged to an acute rehabilitation setting.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
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 Key10029326
MDR Text Key194022963
Report Number9611109-2020-00292
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 05/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16-02-85
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 Received04/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/24/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-2076/2081-2015

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