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

Model Number 4415

Device Problems Obstruction of Flow (2423); Device Displays Incorrect Message (2591); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, there was no flow on the cardioplegia side of the cooler heater unit.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The perfusionist (ccp) noticed bubbles trying to flow and then the unit would go back to "standby" mode.She would try to hit "maintain" mode again, but it would just revert back to "standby" mode.Per the field service representative (fsr), he could not duplicate the reported issue.All modes of cardioplegia operation performed to specifications.The fsr discovered that the main motor would run in cool down mode but had poor flow.When running the unit in rewarm mode, the unit displayed a "pump not primed" error message.The fsr cleaned valve #3 of mineral deposits.He also checked the one-way valve and discovered a plastic cap off of a disposable component.This was causing the obstruction and air bubbles in the valve.The fsr removed the cap from the one-way valve, tightened all hose connections, refilled the cooler heater unit with water and checked all modes of operation.A release test was performed and 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 COOLNG 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: 4249830
• MDR Text Key: 4989798
• Report Number: 1828100-2014-00957
• 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: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• 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
• Date Manufacturer Received: 10/14/2014
• Date Device Manufactured: 10/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1