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 Fluid/Blood Leak (1250); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2010

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) visited the hospital and found two leaks.One was at the front of the unit where the hoses enter the base.The unit was leaking from a hose clamp.The second leak was at valve 6.The polyvinyl chloride (pvc) connector was leaking where it meets the assembly.The fsr noted specifically how difficult these locations are accessible to evaluate.The unit was run in all modes for an extended period of time with no leaks.The system is no longer leaking, and performs to specifications.The fsr noted that the hospital had never done preventative maintenance (pm) or descaling until very recently.The customer would only drain the units and refill them.As a result of the many years without pm, the unit had collected mineral deposits around many of the fittings/connections.When the user began to descale the unit these mineral deposits began to break down, and the resulting leaks occurred.A mdr remediation activity related to manufactured devices with a fda product code ¿dwc: controller, temperature, cardiopulmonary bypass heater cooler" was conducted.This report is a result of the ¿heater ¿ cooler response remediation protocol 02-jun-2016.¿.

Event Description

After use of the device for a cardiopulmonary bypass procedure, the user reported the cooler heater unit was leaking water in the defrost mode.There were no reported adverse consequences to the patient.

• 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: 5719696
• MDR Text Key: 47210016
• Report Number: 1828100-2016-00411
• 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: Other Health Care 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: 10/29/2002
• 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