MalfunctionMSF
POLYFLUX LR CAPILLARY DIALYZER
Received Sep 4, 2008 · Event occurred Jul 18, 2008
Report 9611369-2008-00778 · MDR key 1153101
Device
Manufacturer
Gambro Dialysatoren GmbhModel number
POLYFLUX 6 LRCatalog number
104329
Lot number
7-8104-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. THERE WAS INSIGNIFICANT BLOOD LOSS. NO MEDICAL INTERVENTION WAS NEEDED. NO SERIOUS INJURY.
Additional Manufacturer Narrative
INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBRES. THE SAMPLE HAS NOT ARRIVED FOR INVESTIGATION YET. THE ROOT CAUSE CAN BE DETERMINED AFTER INVESTIGATION.