If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
The complaint device is not being returned for evaluation.
The sales rep troubleshot the pump and determined there was no problem with the device; rather the error code was caused by it was not in the right mode "duo".
The sales rep tested the pump and returned it to service where it has been used for the last year without an issue.
A review into the depuy synthes mitek complaints system revealed two other dissimilar complaints for this device's serial number.
No corrective action is required and no further action is warranted at this time.
Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Dhr review: part number: 284002; supplier lot number: f10a20839; qty of lot: 12.
Release to warehouse date: 3/30/2015.
Manufacturing date: 3/1/2015.
Supplier: (b)(4).
Manufacturing site: (b)(4).
Any anomalies or discrepancies in the manufacture of the lot: no.
This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
(b)(4).
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