MalfunctionMSF
POLYFLUX LR CAPILLARY DIALYZER
Received Sep 4, 2008 · Event occurred Jul 26, 2008
Report 9611369-2008-00755 · MDR key 1153176
Device
Manufacturer
Gambro Diaylzatoren GmbhModel number
POLYFLUX 6 LRCatalog number
109074
Lot number
8-8605-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. THE BLOOD FLOW RATE WAS 110ML/MIN, TMP, 120MGH. 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 FIBRES. 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. GAMBRO DOES NOT REGARD THE SUBMISSION OF THIS REPORT AS AN ADMISSION OF LIABILITY.