MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO TCM II COOLING AND HEATING SYSTEM

Model Number 4415

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the cooler heater unit was leaking from the bottom.The device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2014: per the perfusionist (ccp), the leak was not observed during set-up or priming, and a leak was seen during cpb.It was minor in nature and not isolated to the cooler heater unit until after cpb.The leak did not impact the functional performance of the unit and it was not changed out during the procedure.The case was completed successfully without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

This unit was not in use for the past three to four months and was stored wet in the operating area.The customer defrosts the unit twice a week and a full cleaning once a month.The customer does not utilize chlorine in the cleaning process and has not done so for at least four years.The utilize cageklenz instead for descaling the unit.The field service representative (fsr) verified the leak and replaced the elbow fitting to the cardioplegia (cpg) valve.The fsr performed preventive maintenance (pm) on the cool heater unit.The unit operated to manufacturer specifications and was returned to clinical use.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO TCM II COOLING AND HEATING SYSTEM
• Type of Device: TERUMO TCM II COOLING AND HEATING SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4321626
• MDR Text Key: 20327878
• Report Number: 1828100-2014-01026
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2014

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: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2006
• 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