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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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| Model Number 16-02-85 |
| Device Problem
Microbial Contamination of Device (2303)
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| Patient Problem
Bacterial Infection (1735)
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| Event Date 12/14/2021 |
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Event Type
Death
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Manufacturer Narrative
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Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova held a first call with customer on (b)(6) 2022.Event summary based on (b)(6) 2022 call is below: patient death 4 days post open heart surgery and blood culture was positive for cupriavidus pauculus.3 heater-cooler devices in use at the hospital and 2 tested positive for cupriavidus pauculus and 1 heater-cooler has never tested positive.After repeat disinfection, only 1 device still tested positive, at a very low,non-quantifiable level water monitoring as per ifu was not being conducted.Following this first call livanova has conducted further investigation on cupriavidus pauculus.C.Pauculus is gram-negative, aerobic bacterium and ubiquitous, from ultrafiltered water to swimming pools and ground water.Generally considered a nosocomial infection.In the literature, hydrotherapy pools, nebulization solution, and even bottled mineral water have been recognized as potential sources of contamination.Opportunistic pathogen, but rarely identified as a pathogen in patients.As a gram-negative microorganism with a similar bacterial membrane to p.Aeruginosa, our water maintenance procedures are effective to inactivate c.Pauculus.Cases reported in literature points to a contaminated water source as root cause of infection by c.Pauculus.Complaints database review revealed no previous complaints alleging patient infection associated with 3t contamination with c.Pauculus.Only two complaints from germany were reported to livanova for presence of c.Pauculus in hc device with no report of patient infection.A second call with customer was held on (b)(6) 2022.The outcome of the meeting was that the hospital (b)(6) team believes that the method of transmission for the bacteria was hand/surface transmission and not aerosolization.Indeed, all devices in use at the customer site are equipped with vacuum & sealing upgrade and the customer declared that uses aerosol collection set to prevent aerosolization.Based on investigation findings, literature research and customer feedback from call on (b)(6) 2022, livanova believes that the presence of cupriavidus pauculus in both the patient and heater-cooler is incidental and associated to the ubiquitous nature of the bacterium.Therefore, livanova conclusion is that the reported patient infection is not related to the heater cooler 3t device.No specific action was currently deemed necessary, livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova (b)(4) received a report of a (b)(6) years old patient death occurred on (b)(6).The patient was subjected to a bypass surgery on (b)(6) and a heater-cooler system 3t was used.Post operative shock state, cardiac function preservered, vasodilatory shock state, multi-organ failure were reported and patient went down hill quickly.Reportedly, blood culture were positive for cupriavidus pauculus waterborne, gram negative bacterium.Cultures were finalized on (b)(6).
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Manufacturer Narrative
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Livanova was informed by fda of a medwatch report by the customer.Within the report additional information regarding device serial number and patient conditions were stated.Serial number of device has been added to the dedicated d.4 section as well as udi code and manufacturing date of device has been added accordingly in dedicated h.4 section.Following to device serial number information receipt, a review of the service history records was performed and did not identify any relevant information pertinent to the reported event.Here below additional information which were reported on patient conditions: patient with 1 month of exertional chest pain had work up confirming multi-vessel coronary disease.Patient had cardiac catheterization and echocardiogram which revealed ejection fraction (ef) of 45% and aortic valve sclerosis with mild aortic insufficiency.The patient underwent coronary artery bypass grafting (cabg) x 4 vessels, tolerated the procedure well and was admitted to the cardiovascular intensive care unit (cvicu) on 8mcg/min of norepinephrine.Patient had increasing vasopressor requirements over the next several hours, had right pneumothorax treated with chest tube and re-expansion of lung.Due to increasing hemodynamic instability, patient was unable to be weaned from the ventilator.There was noted escalating serum lactates, creatinine and liver function test (lft) labs.Early on pod (post operative day) #1, noted abdominal discomfort and distension.Surgery was consulted, but no findings per ct for surgical intervention.Transthoracic echocardiogram confirmed good left ventricular function with no tamponade.Shock liver was suspected and supportive measures were in place, however liver dysfunction progressed.Continuous renal placement therapy was initiated however patient continued to decline leading to the decision that further medical treatment was futile and patient passed away 4 days post operatively.Coronary heart disease and hypertension were stated as pre-existing patient conditions which may have contributed to the reported event.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: livanova performed onsite visit to improve knowledge and train the personnel on device instruction for use.Even if the investigation is still in progress and the route of transmission is yet not determined, it can be confirmed that the device was not used according to the instruction for use.In detail the following deviations could be identified: use of cleaning products not listed in ifu.The customer did not spray and let sit for the appropriate time.The customer did not wipe for the appropriate time.The customer communicated that the device was not cleaned each 14 days and it is unknown the frequency of disinfection applied.H2o2 level monitored from monday to friday and not on the weekend.Water quality monitoring not performed before the incident.The customer shut off the vacuum prior patient left the opearting room.Use of quest mps device connected to the heater cooler with a long clear pvc tubing.This device is not between the approved device accessories by livanova and this configuration could be a source of bacterial contamination as the quest mps device was left filled with water.The device currently returned to service.According to the information provided by hospital epidemiologist, the device has been disinfected according to the instruction for use following the event.Although post disinfection reports have not yet been shared by the customer, it was reported that, microbial sampling taken post disinfection was within the acceptable limit reported in the instruction for use.Livanova believes that the presence of cupriavidus pauculus in both the patient and heater-cooler is circumstantial and associated to the ubiquitous nature of the bacterium.It is paramount that further root cause investigation is conducted to determine the source of this contamination.Livanova is currently working with the customer to continue the investigation.Based on investigation findings reported above, it is unlikely that the reported patient infection is caused by heater cooler device.Additional information have been requested to the customer in order to further clarify the reported event.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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See initial report.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: livanova contacted the customer and held interviews with the users and hospital epidemiologists.Primary and secondary cause of the patient death were requested to the customer but the facility did not disclose these as well as any other additional information regarding the reported event.Livanova performed a review of its complaint database and no similar case of patient infection by c.Pauculus was reported.Given the unique nature of the event, livanova performed a literature review with the aim of determining c.Pauculus: epidemiology, microbiology, characteristics as compared to ntm, possible resistance to disinfectants, the nature of known hospital infections, the association with cardio-pulmonary by-pass procedures, diagnosis, and treatment of infections.The review showed that c.Pauculus is an organism commonly found in soil and water and identified as a cause of nosocomial infections in immuno-compromised patient.As compared to ntm acid fast bacilli, c.Pauculus is a gram negative, culture time, as well as symptoms onset, are significantly faster than ntm.Biofilm formation is suspected but has been observed mainly in experimental conditions, as opposed to ntm which is prone to form biofilm and persist in the environment.No resistance to disinfectant appears to be reported.C.Pauculus is an opportunistic organism, with low pathogenicity, that can become pathogenic for immuno-compromised patients.Invasive procedures, such as central venous access or intubation, that are usually considered risk factors for infections, contribute to c.Pauculus infection as well.Patients treated with an adequate antibiotic therapy recover from c.Pauculus infection; patients do not usually die from infection itself, but of associated comorbidities.Among the cases of c.Pauculus infection found in literature, the majority are reported as a nosocomial infection, associated with the use of tube for parenteral nutrition, mechanical ventilation, ecmo thermo-regulator, hemodialysis, central venous catheter and contaminated water.C.Pauculus infections associated to the use of heater - cooler for cardiopulmonary bypass (cpb) procedure do not appear to have been reported in the scientific literature.Based on the investigation performed: the presence of c.Pauculus in the heater cooler device is likely associated with the failure to apply the disinfection and water cleanliness preservation procedures reported in the operating instructions.Since we found no reported c.Pauculus resistance to disinfectants, as well as no reported propensity to form biofilm or aerosolize, we believe that the 3t design solution is at least as effective against c.Pauculus as against ntm.In conclusion, the assignable root cause of the device contamination is failure to follow ifu; customer generally did not adhere to the cleaning and maintenance instructions the assignable root cause of the patient infection is the use environment.The apparent absence of reports in scientific literature of c.Pauculus infections associated with cpb and the absence of similar events reported to livanova, is consistent with this conclusion.
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