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U.S. Department of Health and Human Services

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

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CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE Back to Search Results
Model Number MCH-1000(M)
Device Problems Device Emits Odor (1425); Pumping Stopped (1503); Sparking (2595); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Manufacturer Narrative
Upon inspection of the device, the technician confirmed the customer's report and found that the pump was seized and would not circulate water. The technician first attempted to oil the pump and replace the pump capacitor but the pump was still not functioning. The technician then replaced the pump which resolved the issue and allowed the device to circulate water. The technician then performed an inspection to ensure overall device functionality, for which it passed. Upon review of the service report and the initial customer complaint, it was determined that the pump failure was caused due to a short produced at the plug of the device. The pump is an ac component that directly interfaces with the main ac circuitry of the device and therefore this was the most likely cause of the failure.
 
Event Description
Customer reports that their device produced a spark from the plug, a burning smell was produced and the pump is reported as no longer circulating.
 
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Brand NameCARDIOQUIP MODULAR COOLER HEATER
Type of DeviceCARDIOPULMONARY 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 Key12763524
MDR Text Key281594515
Report Number3007899424-2021-00039
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 Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 10/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMCH-1000(M)
Was Device Available for Evaluation? No
Date Returned to Manufacturer10/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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