2008 SORBENT SYSTEM
Received Dec 30, 2011 · Event occurred Nov 30, 2011
Report 3005778453-2011-00001 · MDR key 2401131
Device
Generic name
Dialysate Delivery. Sorbent Regenerative
Manufacturer
Renal Solutions, Inc.Model number
NACatalog number
NA
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
79 YR
- Dyspnea
- Itching Sensation
- Swelling
- Vomiting
- Urticaria
- Diaphoresis
Narrative
Description of Event or Problem
A (B)(6) REP NOTIFIED (B)(4), THAT A PT BECAME SYMPTOMATIC WHILE ON THE 2008 SORBENT SYSTEM. AFTER ABOUT 2 MINUTES AT BLOOD FLOW RATE (BFR) OF 200 ML/MIN, THE PT CARE TECHNICIAN INCREASED THE BFR TO 400 ML/MIN AS PRESCRIBED. WITHIN ONE MINUTE, THE PT BECAME SYMPTOMATIC AS FOLLOWS: ITCHING, (B)(6), SWELLING OF LIPS, SHORTNESS OF BREATH AND SLIGHTLY DIAPHORETIC. THE PT WAS TAKEN OFF THE DEVICE AFTER APPROX 3 MINUTES OF TREATMENT. THE PT THEN WAS ADMINISTERED 50 MG OF BENADRYL THEN WAS EVALUATED BY A PHYSICIAN AND NOTED TO BE STABLE. APPROX 70 MINUTES LATER, THE PT BECAME NAUSEATED AND BEGAN TO VOMIT. THE PT WAS HOSPITALIZED FOR DIARRHEA BASED ON THE PT'S AGE AND FRAGILE STATE, AND SUBSEQUENTLY WAS RELEASED THE FOLLOWING DAY.