MalfunctionFII
MDR event
Received Feb 6, 2008
Report 9616240-2008-00009 · MDR key 1015270
Device
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IMPROVEMENTS TO INCREASE THE ROBUSTNESS OF THE HYDRAULIC CONNECTORS HAS BEEN APPROVED BY GAMBRO DASCO AND WILL BE IMPLEMENTED IN THE FIELD. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF RESPONSIBILITY FOR THE EVENT. THIS EVENT IS BEING REPORTED AS "MALFUNCTION" UNDER THE MDR 2-YEAR RULE, REGARDLESS OF ANY PT INJURY.