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Model Number MCH-1000(I)
Device Problem Microbial Contamination of Device (2303)
Patient Problem Abscess (1690)
Event Date 04/22/2020
Event Type  Death  
Manufacturer Narrative
The device was not made available to cardioquip for evaluation or testing, despite requests by the manufacturer. Based on communication with the user facility, it was found through further testing that the user facilities water source also tested positive due to current construction. The user facility has yet to determine how the patients contracted the infections.
Event Description
Cooler-heater tested positive for acid-fast bacillus, specifically mycobacterium abscessus. Two cardiac surgery patients where this device has been reported to be used have also been reported to have sternal wound infections consistent with this mycobacteria.
Manufacturer Narrative
On june 11, 2020, cardioquip was notified that an mch-1000(i), s/n (b)(4), tested positive for mycobacterium abscessus. The patient, who had a cardiac surgery procedure between february and march 2020, was reported to have sternal wound infections consistent with mycobacterium. Cardioquip immediately initiated contact with the hospital, (b)(6) medical center (hospital), and requested additional information on the reported event. Initially, cardioquip was denied access to the hospital in order to perform an investigation. The hospital indicated they were hiring a third-party consultant to conduct an investigation. The hospital has refused to provide any information regarding the test protocols used by the third-party consultant. On august 10, 2020, six months after the incident, cardioquip was given limited access to visually inspect three devices. The hospital indicated that they would not allow cardioquip to perform bacterial testing on any cardioquip manufactured devices or other possible hospital sources of infection. All 9 cardioquip devices at the hospital have had no preventive maintenance performed by cardioquip. Preventive maintenance is required according to the ifu (instructions for use) by an "authorized cardioquip service technician every twelve months (annual maintenance section pg. 41). " cardioquip made requests to the hospital staff to provide cleaning, disinfection, and maintenance logs, none have been provided. Cardioquip was given the results in early september, seven months after the patient incident, from the third-party consultants' testing. The testing was performed on april 22nd, one-two months after the patient incident, indicating that the patient and the cardioquip reservoir were found to have the same indistinguishable sub-species of mycobacterium. Testing indicated the cooling fan on the cardioquip device tested negative for mycobacterium. In total, (b)(4) cardioquip devices tested positive for some form of mycobacterium. Further, the hospital shared limited information, that multiple scrub sinks, bathroom sinks, and an ice machine at the hospital were tested and found to have various mycobacterium strains. As recommended by the manufacturer, the cardioquip devices were cleaned and disinfected according to the cardioquip ifu and subsequently retested; all devices tested negative for mycobacterium post cleaning/disinfection. In the "limited access" visit, cardioquip was told by hospital staff that, at the time of the patient incident, a construction project was ongoing at the hospital and the water system was contaminated. "visual inspections only" were performed by hospital staff, from which they stated that the hospital water was cloudy and was clogging the filters used to obtain water for the cardioquip devices. Staff also stated that cardioquip units were drained daily and filled from the scrub sink closest to the device, utilizing a "5 gallon, open bucket. " no bacterial testing was performed on the bucket. The visual inspection on the three units cardioquip was allowed to view showed clear visual contamination in the internal tubing, indicative that cleaning/disinfection had not been performed or was not carried out in accordance with the ifu. Hospital staff informed cardioquip on this visit the specific operating room used during the patient surgery did not utilize a laminar flow system. No other testing data or pertinent information has been provided to cardioquip. The source of bacterial infection is clearly from the hospital water source, and a pathway to patient infection is inconclusive, given the data provided and the time lapse from the patient incident to actual testing.
Event Description
Cooler-heater tested positive for acid-fast bacillus, specifically mycobacterium abscessus. A cardiac surgery patient, where this device has been reported to be used, has been reported to have a sternal wound infection consistent with this mycobacteria. The patient has since expired.
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Manufacturer (Section D)
8422 calibration ct
college station, tx
Manufacturer (Section G)
8422 calibration ct
college station, tx
Manufacturer Contact
melanie harry
8422 calibration ct
college station, tx 
MDR Report Key10271631
MDR Text Key198741036
Report Number3007899424-2020-00004
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMCH-1000(I)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/14/2020 Patient Sequence Number: 1