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

Model Number 4415

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the biomed: they defrost the cooler heater unit once a year during preventive maintenance (pm), the fault indicator light was illuminated for "will not prime", their maintenance process for the unit is they clean condenser fins and filter, oil check functions yearly, their chlorine maintenance schedule is yearly, and use 1 cup of chlorine, no leaks were observed, the water was not cloudy or discolored and there is no knowledge of patient infection that may be associated with the cooler heater unit.

Event Description

The user facility铠biomedical engineer (biomed) reported that during routine testing of the device, she found the cooler heater unit in a constant alarm.There was no patient involvement.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.The field service representative (fsr) verified the reported issue, the cooler heater unit had very sludgy water in the tank and was constantly alarming "pump not primed".The fsr drained the tank, cleaned and flushed the water, removed the pressure sensor and removed debris that was blocking the fitting.The fsr drained and cleaned the tank again, reinstalled the pressure sensor and tested for function.The unit operated to manufacturer's specification 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: SARNS TCM II HEATING AND COOLING SYSTEM
• 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: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5596603
• MDR Text Key: 44024797
• Report Number: 1828100-2016-00272
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2006
• 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