OtherFII
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Received Jan 31, 2008
Report 9616240-2008-00008 · MDR key 996272
Device
Generic name
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Manufacturer
Gambro Dasco S.p.a., Monitor DivisionModel number
*Catalog number
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Lot number
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Product problems
- Normal
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Cardiopulmonary Arrest
- Death
Narrative
Additional Manufacturer Narrative
THE CLINICAL COMPLAINT INVESTIGATION CONDUCTED BY GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT A GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THIS EVENT IS BEING REPORTED AS PER GAMBRO POLICY: ALL CASES OF PT DEATH WITHIN 24 HRS AFTER END OF THE TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE.