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

Model Number 16-02-80

Device Problems Partial Blockage (1065); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Pma 510(k): the heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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).A sorin group field service representative was dispatched to the facility to investigate.The service representative inspected the device and confirmed that the oxygenator heat exchanger was blocked due to the particles and that blue-green precipitate was inside the tubes and on the cooling coils of the evaporator.Additionally, the service representative noted degradation of the protecting nickel layer of the cooling coils in the patient tank.The tubes were replaced and a decalcification cycle was performed.The water tanks and bridges were reported to be clean.Pictures of the unit were taken and sent to sorin group deutschland for further evaluation.The investigation is on-going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the oxygenator filter became blocked with particles coming from the sorin heater-cooler system 3t during a procedure.Blue-green water was also identified inside the tubes of the device.There was no report of patient injury.

Manufacturer Narrative

From follow-up communication, livanova learnt that the customer is maintaining the device as per the guidance provided in the ifu.Livanova has performed comprehensive studies to evaluate the effect of disinfectant on the heater-cooler 3t material.Creation of copper salt was observed during these studies, as well as from devices returned from the field.By considering the age of the device claimed in this complaint, and the results of previous investigation, it is reasonable to conclude that the observed colour of the water is resulting from the dilution in the water tank of the above mentioned salts, resulting from a degradation of the device.From the internal studies performed, it is well known that the extent of the corrosion is related to the exposure of the chemicals used for the device disinfection.It is therefore key that the device is maintained according to the instruction for use.

• 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): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6201399
• MDR Text Key: 63203915
• Report Number: 9611109-2016-00889
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2013
• 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