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

Model Number 4415

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that during use of the device there was poor flow on the cardioplegia.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The field service representative (fsr) could not duplicate the reported complaint.The fsr ran the cardioplegia through all modes and speeds, observed no abnormalities, all valves appeared to be working as expected, and all flow rates observed were as expected.The fsr had a perfusion technician (pt) witness all follow as well.The fsr performed preventative maintenance inspection and test release on the device.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: ERUMO TCM II COOLING AND HEATING SYSTEM
• Type of Device: TCM III 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: 4138620
• MDR Text Key: 4933573
• Report Number: 1828100-2014-00862
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/08/2014

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: 09/08/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2002
• 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