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 10/24/2015

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.The model and serial number of the involved unit have not been disclosed by the facility.This information will be provided in a follow-up report if and when made available.The model number has not been disclosed by the facility, so the 510(k) number is unknown.The serial number has not been disclosed by the facility, so the manufacture date is unknown.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 (mw5058663) stating that the patient displayed mycobacterium abscessus bloodstream infection 2.3 months following an orthotopic heart transplant utilizing a sorin heater-cooler system 3t.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 (mw5058663) stating that the patient displayed mycobacterium abscessus bloodstream infection 2.3 months following an orthotopic heart transplant utilizing a 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).Several attempts were made to obtain more information about the patient and any potentially involved device(s) from the customer.However, sorin group (b)(4) has not received any further information related to this event.As no additional information has been provided by the customer, no additional investigation can be performed.

• 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; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5395190
• MDR Text Key: 36948432
• Report Number: 9611109-2016-00003
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

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?: Yes
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• 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
• Patient Outcome(s): Other