MalfunctionMSF
POLYFLUX R CAPILLARY DIALYZER
Received Aug 21, 2008 · Event occurred Jul 18, 2008
Report 9611369-2008-00750 · MDR key 1135158
Device
Manufacturer
Gambro Dialysatoren GmbhModel number
POLYFLUX 17RCatalog number
109071
Lot number
7-3553-H-01
Product problems
- Fluid/Blood Leak
Patient
NA
- Blood Loss
Narrative
Description of Event or Problem
THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. BLOOD FLOW RATE: 100MIN, TMP: 90G. THERE WAS INSIGNIFICANT BLOOD LOSS. NO MEDICAL INTERVENTION WAS NEEDED. NO SERIOUS INJURY.
Additional Manufacturer Narrative
INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE OF THE HOLLOW FIBERS. NO SAMPLE IS AVAILABLE FOR INVESTIGATION. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.