GAMBRO DIALYSIS MACHINE
Received Apr 3, 2008 · Event occurred Mar 9, 2008
Report 1031723 · MDR key 1031723
Device
Generic name
Dialysis Machine, Crrt
Manufacturer
Gambro Renal Products, Inc.Model number
PRISMACatalog number
*
Lot number
*
Product problems
- Alarm, audible
- Output, high
- Loss of Power
- Repair
Patient
18 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PATIENT ON GAMBRO PRISMA PUMP FOR CONTINUOUS RENAL REPLACEMENT THERAPY. PUMP SET FOR SAFETY LIMIT OF 130 CC OVER THREE HOUR PERIOD. PUMP ALARMED WHEN LIMIT OF 130 CC WAS REACHED, AND SHUT DOWN FOR EXCESSIVE REMOVAL OF FLUID. NEW PUMP OBTAINED AND PLACED ON PATIENT. THERE WAS NO PATIENT HARM FROM THIS EVENT. PUMP SENT TO BIO-MED TO BE CHECKED. BIO-MED REPLACED BLOOD PUMP INSERT, CHECKED PRISMA, CALIBRATED SCALES, CHECKED PRESSURES, AND PODS. PROBLEM COULD NOT BE DUPLICATED. WET TEST DONE AND MACHINE RETURNED TO SERVICE.