MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS TCM II HEATING AND COOLING SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING

Model Number 4415

Device Problems Device Contamination with Chemical or Other Material (2944); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(46).This complaint is related to emdr #1828100-2016-00436.The reported complaint was confirmed.The descaling agent is still available from the manufacturer.This information was passed on to the customer and he will work with his hospital biomed department to order the chemical so that descaling can be done and can continue to be done on a regular basis.Review shows this unit has not been on a regular pm schedule since 2012.(b)(4).

Event Description

The customer reported that during preventive maintenance (pm) of the cooler heater unit, the device contained mineral debris in tank and feels it is because he cannot obtain the proper chemical for cleaning the units.There was no patient involvement.Per clinical review: on april 12, 2016 clinical services (cs) spoke to the perfusionist ((b)(4)) in regards to this issue.The field service representative (fsr) visited this hospital in past week and this customer complained of particulate being in this unit and that he was concerned with the particulate affecting heat exchange performance due to low water flow.He commented to the fsr, he was not able to get the chemicals to keep the unit clean.After my discussion with the (b)(4), he was told by his hospital biomed that the descaling agent (b)(6)) was no longer available for purchase.Cs checked with technical support and b)(6) is still available from the manufacturer.Cs passed this information on to the (b)(4) and he will work with his hospital biomed department to order the chemical so that descaling can be done and can continue to be done on a regular basis.In review of our records, this unit has not been on a regular preventive maintenance (pm) schedule since 2012 and this could be part of the issue.This complaint is based on concern for loss of function and was mentioned during a pm, not during a case.

• Brand Name: SARNS TCM II HEATING AND COOLING SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5721043
• MDR Text Key: 48159509
• Report Number: 1828100-2016-00437
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2005
• 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