MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIOQUIP; HEATER-COOLER

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 06/11/2020

Event Type  Injury  

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 (b)(6) 2020, was reported to have sternal wound infections consistent with mycobacterium.Cardioquip immediately initiated contact with the hospital, beth israel deaconess 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, five 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 (b)(6), six months after the patient incident, from the third-party consultants' testing.The testing was performed on (b)(6), 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, 6 of the 9 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

Patient developed a sternal surgical site infection after undergoing cardiothoracic surgery, where the cardioquip device was used.The isolated organism was identified as m.Abscessus ssp.Bolletii/abscessus.The pathway of infection to the patient has yet to be determined.

• Brand Name: CARDIOQUIP
• Type of Device: HEATER-COOLER
• 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: melanie harry ; 8422 calibration ct; college station, TX 77845 ; 9796910202
• MDR Report Key: 10610134
• MDR Text Key: 209347126
• Report Number: 3007899424-2020-00010
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening