2008 SORBENT SYSTEM
Received Oct 12, 2012 · Event occurred Sep 7, 2012
Report 3005778453-2012-00001 · MDR key 2794752
Device
Generic name
Dialysate Delivery, Sorbent Regenerative
Manufacturer
Renal Solutions Inc.Model number
NACatalog number
NA
Lot number
NA
Product problems
- Device Operates Differently Than Expected
Patient
62 YR
- Low Blood Pressure/ Hypotension
- Itching Sensation
- Sweating
Narrative
Description of Event or Problem
A (B)(6) REPRESENTATIVE NOTIFIED RENAL SOLUTIONS INC (RSI) THAT A PATIENT BECAME SYMPTOMATIC WHILE ON A 2008 SORBENT SYSTEM. WITHIN 5 MINUTES INTO TREATMENT, THE PATIENT PRESENTED ITCHING IN BOTH HANDS, HER FACE FLUSHED, AND WAS MILDLY SWEATY. THE PHYSICIAN LOWERED THE ULTRAFILTRATION GOAL FROM 1800 ML TO 1500 ML AFTER A BLOOD PRESSURE (BP) OF 84/47 FROM A PRE TREATMENT BP OF 124/62 AND STARTING BP OF 116/61. THE PATIENT DID NOT SEEM AT ANY MOMENT TO BE IN MAJOR DISTRESS, WAS COMPLETELY ALERT, AND TALKATIVE. AFTER 10 MINUTES, THE ITCHING DIMINISHED AND BY 45 MINUTES THE SYMPTOMS HAD SUBSIDED. FOR PRECAUTIONARY REASONS THE PATIENT WAS SWITCHED TO A DIFFERENT HEMODIALYSIS MACHINE (2008K MACHINE) TO COMPLETE THE TREATMENT. AT THE END OF THE TREATMENT, THE PATIENT FELT COMPLETELY FINE WITH NO DIFFERENCE FROM OTHER DIALYSIS AND WENT HOME.