inforMED
MalfunctionFIL

FRESENIUS DIALYSIS DELIVERY SYSTEM

Received Jul 24, 2002 · Event occurred Jun 21, 2002

Report 2937457-2002-00036 · MDR key 407798

Device

Generic name

Hemodialysis Machine

Model number

2008K

Catalog number

NA

Lot number

NA

Product problems

  • Inaccurate Flow Rate
  • Output, high
  • Inadequate Ultra Filtration
  • Other (for use when an appropriate device code cannot be identified)

Patient

45 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

FRESENIUS MEDICAL CARE CANADA, INC. REPORTED THAT ULTRAFILTRATION (UF) RATE WAS HIGHER THAN EXPECTED DURING THE FIRST 2 1/2 HRS. OF A HEMODIALYSIS TREATMENT. GOAL WAS SET FOR 3 1/2 HRS. BUT WAS REACHED IN 2 1/2 HRS. TREATMENT WAS COMPLETED WITH THE UF OFF. THERE WAS NO SERIOUS INJURY OR ILLNESS.

Remedial action

  • Other