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

Catalog Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 11/27/2013

Event Type  Injury  

Manufacturer Narrative

No patient information was provided.The model and serial number have not been disclosed by the facility.This information will be provided if and when made available.A serial number has not been disclosed by the facility and so the manufacture date cannot be determined.This information will be provided if and when made available.The model number has not been disclosed by the facility and so the 510k number cannot be determined.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 customer medwatch # (b)(4) stating that a patient was identified/diagnosed with a non-tuberculosis mycobacterium (ntm) infection after undergoing open heart surgery which used a sorin heater-cooler system 3t.The facility has not been able to confirm that the patient infection is related to the use of the sorin heater-cooler system 3t.Two other user reports with the same description were received ((b)(4)).However it is not yet known if the same patient is being referenced in all 3 reports.The medwatch reports 9611109-2015-00663 and 9611109-2015-00664 were submitted for user reports (b)(4), respectively.Multiple requests have been made for information regarding the patient outcome and confirmation of any contamination of the involved device.At this time, the facility has not disclosed any additional information to sorin group (b)(4).The serial number has not been provided by the facility, so a dhr review cannot be performed at this time the investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a customer medwatch # (b)(4) stating that a patient was identified/diagnosed with a non-tuberculosis mycobacterium (ntm) infection after undergoing open heart surgery which used a sorin heater-cooler system 3t.The facility has not been able to confirm that the patient infection is related to the use of the sorin heater-cooler system 3t.

Manufacturer Narrative

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 customer medwatch # (b)(4) stating that a patient was identified/diagnosed with a non-tuberculosis mycobacterium (ntm) infection after undergoing open heart surgery which used a sorin heater-cooler system 3t.The facility has not been able to confirm that the patient infection is related to the use of the sorin heater-cooler system 3t.Multiple attempts were made to contact the customer regarding the serial number(s) of the involved unit(s) and their current status.Additionally, information about the number of patients and their clinical outcomes was requested.None of these attempts were successful.To date, sorin group (b)(4) has not received confirmation that any of the units in use at (b)(6) center are contaminated.No device information was provided by the facility, so a dhr review could not be performed.As no new information has been received from the customer, further investigation is not possible.

• 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): SORIN GROUP DEUTSCHLAND; sorin group deutschland; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5381755
• MDR Text Key: 36460376
• Report Number: 9611109-2015-00662
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2016
• 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 Sequence Number: 1