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U.S. Department of Health and Human Services

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

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SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-80
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Hyperthermia (1909)
Event Date 11/01/2015
Event Type  Injury  
Manufacturer Narrative

The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601). 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 report that 5 to 6 patients experienced hyperthermia after undergoing procedures involving a sorin heater-cooler system 3t. The facility reported that they are disinfecting the device with puristeril 340 according to the current ifu. No issue with the device was detailed in the customer report. The investigation is ongoing. A follow-up report will be sent when the investigation is complete. The customer wishes to retain the unit.

 
Event Description

Sorin group (b)(4) received a report that 5 to 6 patients experienced hyperthermia after undergoing procedures involving a sorin heater-cooler system 3t. The facility reported that they are disinfecting the device with puristeril 340 according to the current ifu. No issue with the device was detailed in the customer report.

 
Manufacturer Narrative

Sorin group (b)(4) has been informed that all of the affected patients survived the reported adverse event after hospitalization in icu. Two of the patients required a tracheostomy. A sorin group field service representative visited the facility and inspected and tested the unit. No issues were discovered during testing and the unit was found to be within specification.

 
Manufacturer Narrative

(b)(4) manufactures the heater-cooler system 3t. The event occurred in (b)(6). This medwatch report is being filed on behalf of (b)(4). After a review of the reported issue conducted by a (b)(4) representative together with the local distributor, it was determined that the reported infections were not related to a malfunction of the heater-cooler device, but to other internal factors at the hospital. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. No device issue identified.

 
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Brand NameSORIN HEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
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 Key5490718
MDR Text Key40018257
Report Number9611109-2016-00129
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 03/31/2017
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 HEALTH PROFESSIONAL
Device MODEL Number16-02-80
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/09/2016 Patient Sequence Number: 1
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