baxter PCA II - Page 66

Specifications
un
Distributors (consignees) are required to REPORT TO THE MANU-
FACTURER the purchase, receipt in trade, return after sale, loss,
destruction or retirement of any tracked medical device.
Required Information:
eName and address of the distributor (consignee)
«Model and serial or lot number of the device
«Dare the device was received
«From whom the device was received
“Date of permanent distribution, i.e.. loss, destruction,
retirement
Upon DISTRIBUTION OF A TRACKED DEVICE FOR USEIN
OR BY THE HOME PATIENT, the following record must be
maintained by the distributor (final or multiple distribucorwho places
the device in the home environment) for the useful life of the tracked
device. Note useful life is defined as the time a device is in use or in
distribucion channels for use.
Required Information:
«Model and serial or lot number of the device
»Patient's name, address and telephone
sDate the device was provided to the patient
ePreseribing physician's name, address and telephone
eAtrending physician's name, address and telephone