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

Model Number 16-02-85

Device Problem Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(4).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that, during a procedure, the temperature displayed on the sorin heater-cooler system 3t was different than the measured temperature at the oxygenator, and the temperature could not be adjusted.There was no report of patient impact.A sorin group field service representative was dispatched to the facility to investigate.The service representative examined the temperature readings on the heater-cooler at low and high ranges for all tanks and all temperatures were found to be within specification.It was discovered during testing that the water level in the patient tank was low.The customer indicated that a patient blanket was used during the procedure, which was not hooked up at the time of testing.The customer did not know if the tank was blinking yellow when the issue occurred.However, it was indicated that the biomedical engineer did basic troubleshooting and found the level low on the patient tank, which was refilled.The unit was found to be operating within specification and was returned to service.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Evaluated on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that, during a procedure, the temperature displayed on the sorin heater-cooler system 3t was different than the measured temperature at the oxygenator, and the temperature could not be adjusted.There was no report of patient impact.

• 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: 5648918
• MDR Text Key: 45009755
• Report Number: 9611109-2016-00318
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2009
• 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