Chapter 8, Cleaning and Maintenance
8-11
Warning!
Leakage current is a primary indication of electrical shock hazard.
Each PCS2 is carefully checked during final factory inspection to
verify that leakage current meets the values specified above in step
7, and is rechecked on a regular basis by Haemonetics as part of
annual preventive maintenance.
The Returned Goods Authorization (RGA) system outlines the procedures
to be followed when returning goods. The system assures 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 are outlined
below. All disposables to be picked up by courier for return to
Haemonetics should be handled according to the Haemonetics Hot Line
instructions. Merchandise shipped in error by Haemonetics will be
handled by the Customer Services Department (800) 356-3506.
1. Call the Haemonetics Hot Line listed previously in this chapter, for
return of any product felt to be unacceptable for patient, donor, or
blood bank use.
2. The Hot Line coordinator will request the following information:
a) product List Number,
b) product Lot Number,
c) the quantity to be returned,
d) the defect noted.
3. Major events, i.e., those that result in a spill or red blood cell loss must
be reported immediately. Examples include any bowl leaks, holes or
cracks in bowl body, as well as any new or unusual defects that have
the potential to result in contamination of the fluid path or could cause
a spill or leak if the bowl were used. It is extremely important that you
do not dispose of such bowls unless so instructed by the Haemonetics
Complaint Coordinator.
Return Goods
Authorization
(RGA)
!
