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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIOQUIP MCH-1000(M)

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CARDIOQUIP LLC CARDIOQUIP MCH-1000(M) Back to Search Results
Model Number MCH-1000(M)
Device Problem Excessive Cooling (2932)
Patient Problem Abdominal Pain (1685)
Event Date 08/02/2019
Event Type  Malfunction  
Manufacturer Narrative

An investigation was conducted on the mch-1000(m), where it was noted that the device had not been serviced by a cardioquip certified technician in over 2 years. Upon inspection, it was discovered, through the use of an electrical safety analyzer, that the leakage current tested over 100[?]a and that the 1600w heater was shorting internally to its chassis, which caused the "main heater" failure alarm. After speaking with the ecmo coordinator, she was not able to definitively identify that the cardioquip mch-1000(m) caused the patients discomfort. She believed that the delivery of colder water to the patient might have caused the abdominal discomfort. The 1600w heater was replaced, and the mch-1000(m) passed a full inspection.

 
Event Description

Ecmo coordinator reported a "heater failure" alert on the start-up screen. However, the unit had been in standby mode and was connected to an ecmo circuit at the time. When the clinician pressed "run" on the cardioquip, it went into "system test" and resulted in the "heater failure" alarm. Also, the patient reported sharp pain in the abdomen. The clinician stated that while in standby, the water would have cooled to room temperature and the delivery of the colder water to the patient caused the sharp pain in the abdomen of the patient which resulted in the discomfort. The clinician ultimately swapped out the unit.

 
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Brand NameCARDIOQUIP
Type of DeviceMCH-1000(M)
Manufacturer (Section D)
CARDIOQUIP LLC
3827 old college rd
bryan TX 77801
Manufacturer (Section G)
CARDIOQUIP LLC
3827 old college rd
bryan TX 77801
Manufacturer Contact
melanie harry
3827 old college rd
bryan, TX 77801
9796910202
MDR Report Key8958001
MDR Text Key190684605
Report Number3007899424-2019-00003
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Repair
Type of Report Initial
Report Date 08/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMCH-1000(M)
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/06/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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