inforMED
DeathFII

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Received Feb 27, 2009 · Event occurred Jan 21, 2009

Report MW4004372 · MDR key 1327639

Device

Generic name

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Manufacturer

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Model number

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Catalog number

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Lot number

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Product problems

  • Unknown (for use when the device problem is not known)

Patient

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  • Death

Narrative

Description of Event or Problem

COMPLAINANT, SPOUSE OF DECEASED, REPORTS THE FOLLOWING: PT, FEMALE DIAGNOSED WITH RENAL FAILURE IN 2008. PHYSICIAN GAVE HER A GOOD PROGNOSIS. HOSPITALIZATION UNTIL FOLLOWING MONTH TO RECEIVE PORTS IN PREPARATION FOR IN-HOME DIALYSIS TREATMENT. RELEASED FROM THE HOSP, AND DEVICE WAS INSTALLED IN HOME ON OR ABOUT THAT SAME TIME. TREATMENT STARTED ON THE FOLLOWING DAY EVERY TUESDAY, THURSDAY AND SATURDAY. PT HAD RECEIVED 6 TREATMENTS WHILE HOSPITALIZED AND 21 AT RESIDENCE. HOME TREATMENTS WERE PROVIDED BY A NURSE. DEVICE INSTALLED IN HOME, AND APPEARS TO BE A 2-PART DEVICE. COMPLAINANT FEELS STRONGLY THAT THIS DEVICE IS RESPONSIBLE FOR THE UNTIMELY DEATH OF HIS SPOUSE. PHYSICIAN INFORMED COMPLAINANT THAT PT'S "BLOOD CONTAINED 12X MORE ACID THAN A NORMAL PERSON."