MalfunctionFII
PRISMASATE 500 CC DIALYSIS SOLUTION
Received Dec 28, 2009 · Event occurred Dec 12, 2009
Report MW5014168 · MDR key 1570788
Device
Product problems
- Crack
Patient
70 YR
- No Information
Narrative
Description of Event or Problem
TWO (2) PRISMASATE DIALYSIS SOLUTION BAGS FOR CONTINUOUS RENAL REPLACEMENT THERAPY BY GAMBRO -BOTH WERE 5000CC EACH- SPLIT FOR PT. WE HAD TO REMAKE THE BAGS. DOSE OR AMOUNT: 5000CC. FREQUENCY: CONTINUOUS. ROUTE: IV. DATES OF: 2009. DIAGNOSIS OR REASON FOR USE: RENAL FAILURE. P3 CONTAINER CRACKED.