Risk Analysis Updates due to complaints

K

Kjb78

#11
Aside form the really good advice to look at every complaint and see fi it provides informative value to improve yoru risk assessmentAND the product performance, I am really struggling with this line and your question:



what is it that Quality is actually trying to do? it sounds like they are either just trying to record the complaint somewhere OR they trying to say "see it isn't so bad, nobody got hurt". What are they trying to bucket?
I am not exactly sure. I believe their intention is to assign the severity level of the complaint based off the risk analysis. When no row in the risk analysis shows that there was no patient harm, (Because for each failure mode a hazardous situation leading to harm is included) then they feel as though selecting the line item in which a hazardous situation occurs resulting in harm, makes their complaint investigation look wrong. They think they are now assigning to the complaint the highest severity of harm if the hazardous situation were to occur, even though it didn't.

Since MDR's are supposed to be submitted if the failure were to recur and the possible harm is of a high enough severity, I thought this was correct.

If I were to answer the complaint I would state in the complaint:

There was no patient involvement and thus no harm, as upon inspection of the device the user noticed the nonconformance or malfunction, and the device was discarded/returned . However, given the failure mode of the device, if the failure/ malfunction/ non conformance were to recur and this would lead to the hazardous situation defined in the risk file, and if the hazardous situation leads to harm, this harm could be of ____________ severity, and thus this is/ is not cause to submit an MDR.

If I had a line item in the risk analysis in which the severity is negligible because I would say the hazardous situation was just such that the device couldn't be used (Non life sustaining/ life supporting device) and a second device had to be then selected, the resultant severity of harm would be negligible, then I would completely miss the fact that if the failure were to recur there is a higher harm severity that should be the determination of submitting the MDR.

Sorry for my run on sentences. I appreciate all of the feedback!
 
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