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

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.

• Brand Name: SORIN HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, 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 Key: 5490718
• MDR Text Key: 40018257
• Report Number: 9611109-2016-00129
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• 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 Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other