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

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, 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
 

SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 12/12/2015
Event Type  Injury  
Manufacturer Narrative
Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The customer was contacted several times, but no further information was received. Litigation is ongoing, which could be a reason why the customer is not providing details. Corrective actions are in progress for this issue. If any additional pertinent information is provided, it will be provided in a supplemental report.
 
Manufacturer Narrative
Patient information was not provided. Model and serial number have not been provided by the facility. This information will be provided in a supplemental report if and when made available. Mfg date: the serial number has not been provided, so the device manufacture date is unknown. This information will be provided in a supplemental report if and when made available. Sorin group (b)(4) manufactures the sorin heater-cooler system 3t. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a user medwatch report (mw5060052) on (b)(4) 2016. The report stated that an adverse event had occurred that involved a sorin heater-cooler system 3t. Multiple attempts have been made to get additional information about the event, however a description of what occurred has not yet been provided. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a user medwatch report (mw5060052) on (b)(4) 2016. The report stated that an adverse event had occurred that involved a sorin heater-cooler system 3t. Multiple attempts have been made to get additional information about the event, however a description of what occurred has not yet been provided.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the sorin heater-cooler system 3t. The incident occurred in (b)(6). (b)(4). Sorin group (b)(4) received a user medwatch report (mw5060052) on february 12, 2016. The report stated that an adverse event had occurred that involved a sorin heater-cooler system 3t. On march, 15, 2016, an update to the user medwatch report (mw5060052) was received. The report states that a patient with history of rheumatic heart disease presented with fevers in 2015 after undergoing a surgical procedure for mitral valve repair and annuloplasty in 2014 that involved a sorin heater-cooler system 3t. The patient developed pneumonia in the hospital and was found to have growth on the prosthetic mitral valve ring. The valve was replaced and tissue cultures were taken. The cultures grew mycobacterium chimaera. Sorin group has still not received information on the involved unit. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSORIN HEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich,
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w 65th way
arvada, CO 80004
2812287260
MDR Report Key5491225
MDR Text Key251364245
Report Number9611109-2016-00118
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 10/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
Was Device Evaluated by Manufacturer? No
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

Patient Treatment Data
Date Received: 03/09/2016 Patient Sequence Number: 1
-
-