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

Model Number 16-02-85

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/20/2015

Event Type  No Answer Provided  

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).Sorin group (b)(4) received a customer medwatch #mw5058118 stating that small black areas were found in a capped portion of tubing on the side panel of the sorin heater-cooler system 3t during quarterly scheduled maintenance.This was the first quarterly maintenance performed on this unit and the customer stated that the cleaning procedure had been followed according to the ifu in the months prior to performing the maintenance.No patient involvement has been reported.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a customer medwatch #mw5058118 stating that small black areas were found in a capped portion of tubing on the side panel of the sorin heater-cooler system 3t during quarterly scheduled maintenance.This was the first quarterly maintenance performed on this unit and the customer stated that the cleaning procedure had been followed according to the ifu in the months prior to performing the maintenance.No patient involvement has been reported.

Manufacturer Narrative

Livanova (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The reporting facility has reported that they are unable to disclose any information regarding potentially contaminated heater-coolers devices due to ongoing litigation.No further investigation is possible.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As corrective action, a field safety notice has been released to remind our customers about the importance of adhering to the water management and disinfection procedure outlined in the current instructions for use (ifu).No information provided by customer.

• Brand Name: SORIN HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; 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: 5349308
• MDR Text Key: 35206504
• Report Number: 9611109-2015-00630
• 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: Risk Manager
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2015
• 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