Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING Back to Search Results
Model Number 4415
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Patient Involvement (2645)
Event Date 09/27/2018
Event Type  malfunction  
Event Description
The manufacturer's technical support specialist reported that during preventive maintenance (pm) of the device, there was low flow when in defrost mode.There was no patient involvement.
 
Manufacturer Narrative
The manufacturer's technical support specialist replaced valve number three resolving the low flow issue while in defrost mode.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.
 
Manufacturer Narrative
The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed there to be corrosion and residue on the valve.The solenoid part of the valve was fully functional.If additional information on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key7992375
MDR Text Key124679266
Report Number1828100-2018-00555
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number4415
Device Catalogue Number4415
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2018
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-