baxter PCA II User Manual

Specifications
This Infusion Pump is Subject to Tracking
Pursuant to Title 21 of the U.S. Code of Federal Regula-
tions, Part 821, "Medical Device Tracking Requirements,"
customers wichin the United States have certain obligations
in furthering che tracking of Infusion Pumps.
You should verify equipment serial numbers against those
listed on the packing slip. Hf correct, indicate this on the
packing slip by signing and dating the slip. Should any of the
information be incorrect, please contact us at 1-800-THE-
PUMP. ‘l'o facilitare funure communications, in addition to
your signature, please print your name, title and telephone
number on the packing slip. Return a copy of the packing
slip to Baxter Healthcare, IV Systems Division.
Any format of verification that provides the required level of
information is acceptable.
Infusion pump tracking within che hospital (or other types of
user facilities) is not required. Please refer to page 43453 of
the rule for further information. However, should you
allocate any of your facility's infusion pumps for home
patient use, you have additional cracking requirements. You
must maintain a current patient and physician registry, by
serial number, in a format that can be provided co the
manufacturer within 5 working days. Should you sell a
pump to a patient, you must promptly provide us with che
patient and physician information,
The final rule on device tracking clarifies the responsibility of
er facilities within the United States.
The following Fact Shcet summarize these requirements. We
hospitals and other u:
would recommend that you develop writren procedures thar
outline your operation's device tracking compliance plan.

baxter PCA II Specifications

General

Brand	baxter
Model	PCA II
Category	Water Pump
Language	English