GAMBRO
Received Mar 13, 2008 · Event occurred Oct 17, 2007
Report 1018451 · MDR key 1018451
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal Products, Inc.Model number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Output, low
- Inadequate Filtration Process
Patient
10 YR
- High Blood Pressure/ Hypertension
- Treatment with medication(s)
Narrative
Description of Event or Problem
MACHINE DID NOT PULL TARGET WEIGHT AND PATIENT REMAINED HYPERTENSIVE AFTER TREATMENT. REQUIRED ONE DOSE OF SUBLINGUAL NIFEDIPINE.