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 Type  Injury  

Manufacturer Narrative

The model and serial number were not provided and the unique identifier (udi) number could not be determined.The event occurred in the usa, so the model is either 16-02-82 or 16-02-85.This information will be provided in a supplemental report if and when made available.The model number was not provided, however, the event occurred in the united states, so the 510(k) number is known.As the serial number is unknown, the device 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).(b)(4).Through follow-up communication with the patient, sorin group learned that the patient did experience an infection following the procedure.The patient reported that he does not have a fever, but that he is experiencing several of the other symptoms described in the letter sent out by the facility.The specific symptoms were not provided.The patient contacted his cardiologist for information regarding what type of testing he would need to confirm if he has the type of infection described in the letter, and his cardiologist reportedly was unable to provide an answer.It was suggested to the patient to contact the number on the letter, and the message was then forwarded to sorin group.The patient reported that he had not made any attempts to contact sorin group, and would not expect the device manufacturer to know which tests are needed.It is unknown at this time if the symptoms experienced by the patient are in any way related to a mycobacterium infection or the involved 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 report stating that he is experiencing at least 3 of the symptoms described in a letter he received from his hospital ((b)(6)) regarding the sorin heater-cooler system 3t.The patient asked about what blood tests are needed to identify the type of bacteria, as his cardiologist does not know which tests to perform.

• 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: 6068861
• MDR Text Key: 58815030
• Report Number: 9611109-2016-00734
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• 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: 10/10/2016
• 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
• Patient Age: 65 YR