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Received Sep 18, 2008
Report 9616240-2008-00051 · MDR key 1163328
Device
Generic name
*
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
- Death
Narrative
Additional Manufacturer Narrative
THE MACHINE WAS INSPECTED BY A GAMBRO SVC TECH ON (B)(4) 2008. HE FOUND THE MACHINE TO BE PROPERLY CALIBRATED, FUNCTIONING CORRECTLY, AND WITHIN MFR'S SPECS. THE MACHINE HAS BEEN RETURNED TO SVC, WITH NO PROBLEMS REPORTED. NEITHER THE PHYSICIAN, NOR THE CLINICAL STAFF BELIEVES THAT A DEVICE MALFUNCTION OCCURRED, NOR DO THEY BELIEVE THAT A GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THE PT'S DEATH. THIS EVENT IS BEING REPORTED PER GAMBRO POLICY: ALL CASES OF PT DEATH OCCURRED DURING TREATMENT OR WITHIN 24 HRS AFTER END OF THE TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE.