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Received Jun 23, 2008
Report 9616240-2008-00034 · MDR key 1076186
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
- Death
Narrative
Additional Manufacturer Narrative
FACILITY NURSE MGR STATED THAT SHE REPORTED THIS EVENT SO THE MACHINE COULD BE INSPECTED AND CLEARED BY A GTS REP. SHE FURTHER STATED THAT SHE WAS CERTAIN THAT A GAMBRO PROD DID NOT CAUSE OR CONTRIBUTE TO THIS REPORTED EVENT. A GTS REP INSPECTED THIS PHOENIX MACHINE AND, AFTER COMPLETING A SERIES OF TESTS, FOUND THAT IT PERFORMED ACCORDING TO MFR'S SPECS. THE MACHINE IS CURRENTLY IN SVC WITHOUT PROBLEMS. GAMBRO DOES NOT REGARD THE SUBMISSION OF THIS REPORT AS AN ADMISSION OF LIABILITY. 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.