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

Model Number 4415

Device Problems Device Reprocessing Problem (1091); Restricted Flow rate (1248)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

It was reported by the field svc rep (fsr) that during troubleshooting of mdr #1828100-2015-00437, the flow over the cold plate seemed less than normal on the cooler heater unit.There was no pt involvement.

Manufacturer Narrative

This complaint is related to mdr #1828100-2015-00161 and mrd #1828100-2015-00437.The field svc rep (fsr) corrected the low flow by cleaning out the internal filter.Flow now appeared normal and the cooler heater unit was operating in all modes.The unit operated to mfr spec and was returned to clinical use.If add'l info 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: 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: 4808445
• MDR Text Key: 5893185
• Report Number: 1828100-2015-00438
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2007
• 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