MalfunctionFII
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Received Jan 22, 2008
Report 9616240-2008-00005 · MDR key 1000493
Device
Generic name
*
Manufacturer
Gambro Dasco S.p.a., Monitor DivisionModel number
*Catalog number
*
Lot number
*
Product problems
- Disconnection
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IMPROVEMENTS TO INCREASE THE ROBUSTNESS OF THE HYDRAULIC CONNECTIONS HAVE BEEN DESIGNED AND VALIDATED AND ARE CURRENTLY BEING INTRODUCED IN THE FIELD TO AVOID THE OCCURRENCE OF TUBING DISCONNECTION. THIS EVENT IS BEING REPORTED AS "MALFUNCTION" UNDER THE MDR 2-YEAR RULE, REGARDLESS OF ANY PT INJURY.