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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/10/2014

Event Type  Injury  

Manufacturer Narrative

Patient age was not provided.This information will be provided in a supplemental report if and when made available.Patient weight was not provided.This information will be provided in a supplemental report if and when made available.The model and serial number were not provided and the udi number could not be determined.This information will be provided in a supplemental report if and when made available.Initial reporter: the initial report was not received by a facility, but from the patient herself, who provided the facility name and address where the event took place.Mfg date.A serial number was not provided, so the manufacture date could not be determined.This information will be provided in a supplemental report if and when made available.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 received a call from a patient regarding an infection.The patient underwent open heart surgery on (b)(6) 2014 and later presented with a wound infection, which lasted for 6 months.Through follow up communication with the patient, sorin group learned that the patient had to go to wound care every two weeks during the healing process.It is unknown if cultures were taken.During the infection, the patient symptoms included loss of energy, sweats (which have subsided), memory loss, and nausea/vomiting.The patient received a letter from her cardiology office stating that the sorin heater-cooler system could be a source of infection, which prompted her to call the company.A copy of the letter was requested, but the patient was unable to easily send it.Sorin group contacted the facility for a copy of the letter, which was provided.The letter confirmed that the procedure involved a sorin group heater-cooler system 3t.The original wound is now healed completely, but recently a new small opening appeared.The new wound is healing and there is no new infection.The patient has forwarded the sorin group contact information to her personal cardiologist and her primary care physician.However, the cardiologist has not yet contacted the company.This report was received from the patient on (b)(6) 2016 and did not come from the facility.The facility where the infection occurred (b)(6) has previously filed a user medwatch report (mw5060415) stating that four (4) of the facility's five (5) units were found to be contaminated.Sorin has filed a medwatch report for each of the contaminated units (reference report numbers 9611109-2016-00231, 9611109-2016-00232, 9611109-2016-00233, 9611109-2016-00234), but there have been no reports of patient infection from the facility.It is unknown which unit was used for this procedure.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a call from a patient regarding an infection.The patient underwent open heart surgery on (b)(6) 2014 and later presented with a wound infection, which lasted for 6 months.

• 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: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5718781
• MDR Text Key: 47190283
• Report Number: 9611109-2016-00347
• 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: other
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2016
• 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
• Patient Outcome(s): Other