Haemonetics MCS+, Operator And Maintenance Manual

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Maintenance 6-13
P/N 39551-00, Rev. F
R
ETURNED
G
OODS
A
UTHORIZATION
(RGA) S
YSTEM
The Returned Goods Authorization (RGA) System outlines the procedures to be
followed when returning goods. The system ensures that returned goods are
properly handled and analyzed. Because of the potential health hazard inherent
in the shipment, handling, and defect analysis of biologically contaminated
products, it is important that these procedures be carefully followed.
RGA
Procedure
The steps that should be followed in returning any equipment or disposable are
outlined below. All disposables to be picked up by courier for return to Haemon-
etics should be handled according to the coordinator’s instructions. Merchandise
shipped in error by Haemonetics will be handled by the Customer Services De-
partment, at (800) 225-5297.
1. Call the Product Complaint Coordinator at (800) 225-5242, x9622, to return
any product you feel is unacceptable for patient, donor, or blood bank use.
2. The coordinator will request the following information:
a. Product list number.
b. Product lot number and outdate.
c. The quantity to be returned.
d. The defect noted.
e. The number of cartons being returned.
3. The coordinator will inform you of the additional steps that need to be taken
at this point.
4. If the disposables have been exposed to blood, you must provide a detailed
description of the problem you experienced. You must also supply the same
information as detailed earlier (i.e., product list number, lot number, etc.). In
many situations, you will be asked to dispose of these goods after reporting
the defect.
5. Should Haemonetics request the return of contaminated disposables or
equipment, the disposables or equipment must be decontaminated prior to
shipment pursuant to those policies and procedures dictated by the medical
facility’s Exposure Control Plan, as required by OSHA Bloodborne Pathogen
Standard. Repackaging of equipment or disposables for return to Haemonet-
ics must comply with U.S. Department of Transportation regulations for in-
terstate shipment of blood-contaminated products.
Warning! Materials returned unwashed cannot be analyzed
and pose a potentially serious health hazard to individuals in-
volved in shipping, handling, and testing.