Model Number 16-02-80 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no known patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This device undergone deep disinfection in the past.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Further information in order to clarify the reported issue has been requested.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 that a heater-cooler system 3t device was found to be contaminated with high colony count of >6200 cfu/ml.There is no known patient involvement.
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Manufacturer Narrative
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H.10: through follow-up communication livanova learned that the device was commissioned following disinfection protocols as per ifu and send for testing.It was placed outside the operating theatre.The laboratory report confirming the reported issue has been provided.However, the post deep disinfection (post-dd) tests conducted at the manufacturer site before device release demonstrate that the deep disinfection process was successful.It is likely that a contamination of the samples may have led to the reported false positive results.However, this is not confirmed at the moment and the customer is planning a second test for this device.No further information is available about this case up to date.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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Manufacturer Narrative
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H10: the investigation of the of the contamination event pointed out the following potential causes: unsuccessful deep disinfection process.This potential root cause can be reasonably ruled out.The post deep disinfection (post-dd) tests conducted at the manufacturer site before device being released to the customer, demonstrate that the deep disinfection process was successful.Transportation damage leading to loss of packaging integrity.This potential root cause can be reasonably ruled out.Through follow-up communication, livanova learned that the device packaging was not damaged when arrived.False positive due to contamination of water samples during sampling process.This potential root cause cannot be excluded.The customer did not conduct any confirmatory re-test of the device and this potential root cause cannot be definitively confirmed.Contamination during installation at customer facility.This potential root cause can be reasonably ruled out.Through follow-up communication, livanova learned that device packaging was removed before device entering the operating theater premises and that the device was installed on the same day.Reportedly the device was cleaned as per the instruction for use and a pall filter was used for tap water.No evident deviation has been reported in the installation procedure.Based on the result of the investigation the most likely cause of the observed high bacterial count was a false positive result due to the inadvertent contamination of the water samples during sampling operation at customer site.Due to the absence of a second confirmatory test from the customer, this potential root cause cannot be definitively confirmed.
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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: through follow-up communication with the customer livanova learned that no repeated testing of the device was performed at the customer site following the event of high bacteria count.Nevertheless, reportedly the machine was put back in clinical use between january and march 2020 and that last use was on 17 march 2020 with no further report of a high bacteria count.After 17 march 2020, the unit was not used and no testing was done until july 2020 since the device was repaired in june 2020.Results of the july 2020 test were received in august 2020 and revealed device positivity to m.Chimaera (this is a different type of contamination in respect to the one reported as part of this complaint) and this event was captured in a separate complaint and reported under mfr report number: 9611109-2020-00552.Thereafter unit has been destroyed/discarded by the customer in september 2020.Given the different type of contamination found in aug 2020 (m.Chimaera) it¿s unlikely that the second contamination event is related to the first event object of the present complaint.At the current level of knowledge it's unlikely that the device was release post deep cleaning as contaminated.We cannot exclude that the observed high bacteria count was the result of the inadvertent contamination of the sample during the sampling operation.However livanova is doing an additional attempt to collect more precise information and will file any relevant information obtained in a supplemental report.
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Search Alerts/Recalls
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