MalfunctionMAC
LEVCOREDUCTION FILTER
Received Jul 9, 2004 · Event occurred May 20, 2004
Report 9710488-2004-00001 · MDR key 5404929
Device
Generic name
Medical Device
Manufacturer
Macoproductions S.a.s.Model number
KSV0002XDLot number
284803G22
Product problems
- Fluid/Blood Leak
- Filtration Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO. 133900 FILTER SIMILAR PRODUCTS SOLD IN (B)(6) WITHOUT ANY COMPLAINT ABOUT LEAK. POTENTIAL CONTAMINATION VERY LOW. INVESTIGATION STILL ONGOING AT THIS DATE.
Description of Event or Problem
LOSS OF INTEGRITY OF THE FILTER DURING FILTRATION. BLOOD LEAKED FROM FILTER. FILTRATION CONDITION: BLOOD STORAGE 1 DEGREE BEFORE FILTRATION 22 CELSIUS. BLOOD STORAGE TIME BEFORE FILTRATION 5 HOURS. FILTRATION 1 DEGREE - 22 CELSIUS. FILTRATION TIME; APPROX. 6MM. BLOOD CENTER: GULF COAST. DURATION NUMBER: (B)(4).