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

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND 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
 

LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Fatigue (1849); Fever (1858); Muscle Weakness (1967); Sweating (2444); Weight Changes (2607)
Event Date 07/09/2015
Event Type  Injury  
Manufacturer Narrative

The serial number is unknown. This information will be provided in a supplemental report if made available. The initial report did not specify a hospital. It is unknown where the event occurred at this time. 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. Livanova (b)(4) manufactures the heater-cooler system 3t. It is unknown where the event occurred. This medwatch report is being filed on behalf of livanova (b)(4). Multiple attempts have been made to follow-up with the patient regarding the hospital where the surgery took place and the nature of the symptoms that are being experienced. No further information has been provided at this time. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Event Description

On (b)(6) 2017, livanova (b)(4) received a medwatch report (mw5069631) from a patient who underwent open heart surgery in (b)(6) 2015. The surgery utilized a heater-cooler system 3t. Upon receipt of a letter from the hospital stating that patients may have been infected by the device, the patient reported to the hospital that he is displaying most of the symptoms. The patient was advised by the hospital to be tested for mycobacterium chimaera. However, the patient is reportedly unable to afford the testing and has not been tested at this time.

 
Manufacturer Narrative

(b)(6). Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). This medwatch report is being submitted on behalf of livanova (b)(4). Through follow-up communication with the patient, livanova (b)(4) received additional information regarding the involved facility and the patient symptoms, which include night sweats, muscle aches, fatigue, unexplained fevers and unexplained weight loss. The patient requested information on the blood tests required to diagnose this type of infection. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). A follow-up communication with the risk management of the facility reveiled that the facility is in communication with the patient, and that they are arranging to have the testing done, but still it is unknown if the patient is infected or not. No further details were received. This complaint has been forwarded to the legal department. Livanova (b)(4) will close this complaint, however, should any pertinent additional information be received it will be provided in a supplemental report. No device malfunction, neither an adverse event could be identified from this report, however, corrective actions are in progress for similar described events. Device not returned.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA 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 Key6685476
MDR Text Key79025678
Report Number9611109-2017-00506
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation PATIENT
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 01/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number16-02-85
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/04/2017 Patient Sequence Number: 1
-
-