MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING

Model Number 4415

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative was dispatched to the user facility.

Event Description

It was reported that during the use of the device for a non-clinical activity, the user facility biomedical engineer (biomed) attempted to repair the heater cooler unit and found out that the rear of pump housing had melted due to lack of water in the pump.There was no patient involvement.

Manufacturer Narrative

The rear housing of the pump had melted interfering with the impeller functionality.Without the impeller turning the cardioplegia pump could not circulate water.At this time, the only choice for the field service representative (fsr) was to replace the whole pump to resolve the melted housing interference with the impeller function.Per fsr and the user facility biomedical engineer (biomed), the reason for the melted housing was due to the tcm, at some point, being run or used without water.

Manufacturer Narrative

The field service representative (fsr) replaced the cardioplegia (cpg) pump and checked the operation.He noted a lot of debris in water (granules) and hoses show signs of deterioration due to too much chlorine in system.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) found that the pump's surface contained rust and residue.The impeller was missing it's shaft.There was no evidence of melting on the returned part.

Manufacturer Narrative

The reported complaint was confirmed.The field service representative (fsr) and user facility biomedical engineer (biomed) concluded that the melted housing was due to unit at some point was being run or used without water.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: SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
• 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: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6096784
• MDR Text Key: 60076987
• Report Number: 1828100-2016-00733
• 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,Followup,Followup,Followup,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2003
• 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