PRISMASATE DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT THERAPY 5000ML BAG
Received Dec 2, 2009 · Event occurred Dec 2, 2009
Report MW5014012 · MDR key 1562922
Device
Product problems
- Fluid/Blood Leak
- Material Separation
- Split
- Contamination of Device Ingredient or Reagent
- Material Integrity Problem
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
PRISMASATE DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT THERAPY TWO COMPARTMENT BAG SEPARATED BY A PEEL SEAL. (BGK 2/0) 5000 ML BAG. LOT # P9G304, EXP DATE: 01/2011. WHEN ATTEMPTING TO MIX THE PRODUCT CONTENTS, THE PEEL SEAL SPLIT OPEN, RESULTING IN THE PRODUCT CONTENTS POURING OUT OF THE BAGS. WE HAVE ALSO BEEN EXPERIENCING BAG LEAKAGE WITH THESE PRODUCTS. WE DO NOT HAVE THE LOT NUMBER OR EXP DATE FOR THOSE BAGS. CONCERN ABOUT PRODUCT CONTENT INTEGRITY/CONTAMINATION WITH THE LEAKING BAGS. DOSE OR AMOUNT: 3000 ML; FREQUENCY: PER HOUR; ROUTE: IV. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: CONTINUOUS RENAL REPLACEMENT THERAPY.