Cartridge test on a Gambrio Phoenix


#1

Hi there, who could be helping me in testing a disposable cartridge i have developed on Gambro Phoenix Cartridge with no patient connected and no blood running, but, water?
i can pay for this service, nothing is for free
thank you for your comments
kindest regards
Francesco


#2

Francesco, new technology needs to be tested in animals first, and then in a series of human trials for safety and efficacy. asking for volunteer guinea pigs is not legal in the US.


#3

Dori, thank you for your reply!
this is not a new technology, we sold few hundred thousands of these already in Europe in the least years and we carry all european ISO standard certifications for this. I do need a “in vitro” testing partner to enclose the result of the testing in my FDA file.
so, test will be done with water and no patient connected, of course, it is just to check if the cartridge fits the machine and it does, just that, the test will paid and it will take not more than 30 minutes
however thank you for your reply and any suggestions from you side are very welcome and appreciated
kindest regards
Francesco


#4

Okay, so it may be that what’s needed here is a better description of what you are hoping to do and how…


#5

Hi Dori, sorry for my delay in replying;
what i need is someone using Gambro Phoenix who is interested in helping me, i will pay for this help, in testing our disposable bloodline for Gambro Phoenix with NO PATIENT and NO BLOOD involved in the test,. Product is fully certified in Europe and successfully used since years, but, i need to perform this test for our FDA 510(k) file we are building up to start selling in USA. if someone might be interested in this i can answer to any further questions
thank you
Francesco


#6

Ill give your Cartidges a try I have machines in Manila i can test it on if you wish id be interested to see how they perform


#7

Hi Antonio and thank you for your attention to my needs; i am sorry but, the test must be done within the US…but thanks again for your help
have a goodnite
kindest regards
Francesco


#8

Out of curiosity could i ask if i could get your supplier info so if possible i could try them out as well


#9

Hi Antonio and thank you for your attention, my supplier is myself, i am the manufacturer
we are located in Germany and we do manufacture millions of AV sets per year, including the Gambro cartridge, but, for the European market since almost 20 years
we need just for FDA bureaucracy to test these products within the US
are you working with Gambro Phoenix? where are you located?
thank you and looking forward to read from you
kindest regards


#10

Antonio, I think you really need to reach out to Gambro directly. The company is now owned by Baxter. The US FDA is not likely to accept data that doesn’t come from an approved trial. This doesn’t seem like something you can do informally on your own, unless you purchase a machine.


#11

Thanks for the input but I’m not in the States my Dialysis center just received 21 Refurbished Gambro Phoenix Machines here in Manila, Philippines not in the States. Right now we have been planning to try some cartridges made in Taiwan for Gambro machines but I’m interested in trying these cartridges from Europe this is why I’m asking. We have also access to Baxter Cartridges thru their Distributor/Dealer but they are quite expensive. In the thread I only offered to let our friend here run tests on the machines for his cartridge but he declined because he wanted US based testing . I however am also interested in possible alternate Cartridge Suppliers.


#12

Hi Antonio, i will be glad to send you free samples for testing our cartridges and many other of our dialysis products, please, just give me your address to send and thank you
kindest regards
Francesco


#13

Hi Dori, we already are in touch with FDA of course, this is an approved trial, the testing we need are to fill our FDA testing protocol for 510(k)
i can’t go by Gambro Baxter to ask testing something in competition with them…
however thank you and compliments for your blog which is of help to keep everybody in touch on dialysis matters
have good day
Francesco


#14

Hi Francesco, That would be great looking forward to reviewing what goodie you have to offer

Antonio
Office: +6326350331
Email: antonio@globalfundtrading.net

Aruga Dialysis Center
Unit 1-B G/F, Unique International Bldg.,
No.1 Cordillera Corner Sierra Madre,
Mandaluyong, NCR 1550 Philippines


#15

Francesco,
Have you been able to send an email yet


#16

Thank you for letting us know that, Francesco. I think if you had started out by saying that you have an FDA-approved trial, you might have gotten more replies.


#17

Dori that test has been done already and it has been using water instead of blood, without patients connected and I paid 2’500 dollars for this 1 hour long test performed in a US dialysis clinic, it was so simple and easy but nobody in this blog took ny opportunity


#18

Hi Antonio I will ask to the company to send you some free samples shortly, sorry for my delay and have a good day