Copy of email submitted to FMC as a complaint. When I have a ref no I'll add it - support from other tech services would make it more powerful.
Shunt_interlock_orientation_v2.docxI’d like to open a complaint about a new spare part please. This is about the shunt interlock device for the 5008H model
Old Part No F40001212 - £116 +VAT
New Part No F50014608 - £498 + VAT
Whilst the change in price is shocking enough there is also a patient safety aspect that seems to have been overlooked with respect to this new ‘gold-plated’ assembly. Some technical explanation is included within the attached document.
Nowhere in the fitting instructions does it mention to check the orientation of the Red and Blue connectors/tubing are correct for the dialysis unit in which they’re installed. Unless the person fitting the new assembly is very carful and diligent there is a high risk that the tubing will be connected the wrong way around.
• This would mean that the blood and dialysis fluid flow through the dialyser would not be counter-current which is a risk to patient safety as it will significantly reduce the efficacy of the treatment and may lead to increased clotting within the dialyser.
• There is also a strong chance that staff used to fitting the connectors one way round would connect the tubing returning from the dialyser to the wrong connector on the shunt interlock. This would pose an increased infection control risk.
I shall post a copy of this email on the ART discussion forum to warn other customers of this outrageous price increase and heighten awareness of this these risks within the technical community.
Locked
