(b)(4).Potential lot number: 13f19d0025, 13f18a0389, 13f19d0025, 13f19d0025, 13f19j0416.
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Qn#(b)(4).The report "catheter tip location incorrect" was not confirmed since the sample was not returned for review.A device history record review was performed and did not reveal any manufacturing related issues.However, this complaint is one of eighteen associated complaints filed at the same time for "it is unknown why the trace showed an increase on the p-wave when it was not in the lower 1/3 of the svc", or in other words "clinicians reported that catheter tip placement when using the vps rhythm device does not correlate to confirmatory chest x-rays".Each of the complaints was accompanied by a photo of the tip confirmation checklist for the procedure being performed.A material sample was not returned for any of the complaints.No copies of the chest x-rays were provided for review.The sr.Global strategic clinical marketing manager reviewed all eighteen complaints.The sr.Global strategic clinical marketing manager concluded, based on the observations of the tip confirmation checklists, it is possible that when using confirmatory chest x-rays, appropriate techniques were not followed to remove cxr variables.These variables include keeping the patient in the same position as when the catheter was placed, keeping the head of the bed in the same position as when the catheter was placed, having the chest x-ray tube at a 90 degree angle towards the patient and the patient flat, and having radiology read each confirmatory chest x-ray in the same manner.These variables are well documented in published clinical studies.It is recommended that clinical education be provided to the clinicians managing the account.A corrective action is not required at this time.However, based on the information provided by the sr.Global strategic clinical marketing manager, the probable root cause is user error -unintentional - clinician technique.Based on the recommendation of the sr.Global strategic clinical marketing manager, an in service is being requested to review appropriate techniques to remove cxr variables.
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