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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 10/11/2012

Event Type  Injury  

Manufacturer Narrative

The model number was not provided, so it is unclear whether a sorin heater-cooler system 3t (510k#: k052601) or a sorin heater-cooler system 1t (not distributed in usa) was involved.This information will be provided in a supplemental report if and when made available.The model and serial number were not disclosed by the facility.This will be provided in a supplemental report if and when made available.The model number was not provided, so the 510(k) number is unknown.This will be provided in a supplemental report if and when made available.The serial number was not provided, so the manufacture date is unknown.This will be provided in a supplemental report if and when made available.Sorin group (b)(4) manufactures the sorin heater-cooler system.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 a patient was diagnosed with gastroenteritis caused by atypical mycobacteria.The patient underwent a surgical procedure involving a sorin heater-cooler system on (b)(6) 2012.The model and serial number have not been provided by the facility.The facility owns both sorin heater-cooler system 3t units and sorin heater-cooler system 1t units (which are not distributed in the usa), so it is unknown which system was involved in the event.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that a patient was diagnosed with gastroenteritis caused by atypical mycobacteria.The patient underwent a surgical procedure involving a sorin heater-cooler system on (b)(6) 2012.

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Several attempts have been made to contact the customer and retrieve additional information regarding patient details and the involved device.No further information was provided during these follow-up attempts.However, during follow-up communication made independently from this event, the customer disclosed that the facility's heater-cooler devices have been removed from service and quarantined by the medical engineering department until a "rework" can be performed.Additional details about the rework and when it will be completed were not provided.

• Brand Name: SORIN HEATER-COOLER SYSTEM
• 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: 5448305
• MDR Text Key: 38628685
• Report Number: 9611109-2016-00046
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other