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: CINCINNATI SUB-ZERO PRODUCTS, INC. HEMOTHERM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
  • 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
 

CINCINNATI SUB-ZERO PRODUCTS, INC. HEMOTHERM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 400CE
Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2018
Event Type  malfunction  
Event Description
During rewarming, unit was functioning properly.When patient reached 37 degrees, the unit stopped circulating water and the patient cooled down to 36 degrees.The second unit was retasked to warm the patient to 37 degrees.This required a total of 25 minutes of additional bypass time.Manufacturer response for heater cooler, cincinnati sub zero heater cooler (per site reporter): cincinnati sub zero representative consulted re: the equipment.Speaking with tech support, he determined that the power board was the issue.The pump fuse had blown.We received the new board, installed it, and ran it for several hours in the biomed shop.Our employee then completed the preventative maintenance on it before returning it to service.No further issues.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEMOTHERM
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 mosteller road
cincinnati OH 45241
MDR Report Key7548585
MDR Text Key109389928
Report Number7548585
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number400CE
Device Catalogue Number86022
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/22/2018
Event Location Hospital
Date Report to Manufacturer05/22/2018
Type of Device Usage N
Patient Sequence Number1
Treatment
ANESTHESIA MACHINE, IV PUMPS, CINCINNATI HEATER CO
Patient Age52 YR
Patient Weight20
-
-