MalfunctionMSF
POLYFLUX LR CAPILLARY DIALYZER
Received Jul 24, 2008
Report 9611369-2008-00654 · MDR key 1080065
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Product code (MSF)
Manufacturer (Gambro Dialysatoren Gmbh)
Model (POLYFLUX 8 LR)
Device
Generic name
None
Manufacturer
Gambro Dialysatoren GmbhModel number
POLYFLUX 8 LRCatalog number
104333
Lot number
7-8207-H-01
Product problems
- Fluid/Blood Leak
Patient
Not reported
- Blood Loss
Narrative
Description of Event or Problem
THE CUSTOMER COMPLAINS OF BLOOD LEAK DURING THE TREATMENT. THE BLOOD LOSS WAS INSIGNIFICANT. NO PT HARM AND NO MEDICAL INTERVENTION WAS NEEDED.
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.