• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER; CARDIOPULMONARY BYPASS DEVICE

  • 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
 

CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER; CARDIOPULMONARY BYPASS DEVICE Back to Search Results
Model Number MCH-1000(I)
Device Problems Insufficient Cooling (1130); Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
Manufacturer Narrative
The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The customer notified cardioquip that a patient was involved during the malfunction although no patient information was communicated.Cardioquip's investigation determined that the issue cannot be confirmed.Following replacement of the cpg valves as a preventative measure, the device passed inspection and is fully operational.
 
Event Description
The customer reported that the unit cpg is not heating or cooling while on bypass.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARDIOQUIP MODULAR COOLER HEATER
Type of Device
CARDIOPULMONARY BYPASS DEVICE
Manufacturer (Section D)
CARDIOQUIP, LLC
8422 calibration ct.
college station TX 77845
Manufacturer (Section G)
CARDIOQUIP, LLC
8422 calibration ct.
college station TX 77845
Manufacturer Contact
charley ford
8422 calibration ct.
college station, TX 77845
9796910202
MDR Report Key15606552
MDR Text Key305539803
Report Number3007899424-2022-00150
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Remedial Action Repair
Type of Report Initial
Report Date 07/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMCH-1000(I)
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-