F5 DIALYZER FINISHED ASSY
Received May 19, 2011 · Event occurred Apr 22, 2011
Report 1713747-2011-00012 · MDR key 2117139
Device
Generic name
Dialyzer
Manufacturer
Ogden ManufacturingModel number
NACatalog number
0500162R
Lot number
10LU04012
Product problems
- Leak/Splash
Patient
15 YR
- Blood Loss
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
WHILE PATIENT WAS RECEIVING HER HEMODIALYSIS TREATMENT, THE NURSE NOTICED BLOOD LEAKING FROM THE VENOUS HEADER END CAP. IT WAS REPORTED THAT THE ESTIMATED BLOOD LOSS WAS 10 ML. THE NURSE REPORTED THAT THE HEADER END CAP WAS NOT TIGHTLY SEALED AND THAT THEY TRIED TIGHTENING IT. THEY BELIEVE THIS WAS THE CAUSE OF THE BLOOD LEAK. THE NURSE SAID THAT THE PATIENT IS FINE. THIS PATIENT DID COMPLETE THE ENTIRE TREATMENT AFTER THIS EVENT WITH USE OF NEW PRODUCT WITHOUT FURTHER INCIDENT. THERE IS NO REPORTED ILL EFFECT OR MEDICAL TREATMENT GIVEN. A SAMPLE IS AVAILABLE FOR AN EVALUATION. THE PATIENT WAS DISCHARGED TO HER HOME WHEN THE TREATMENT WAS COMPLETE.