inforMED
MalfunctionFIL

FRESENIUS DIALYSIS DELIVERY SYSTEM

Received Feb 15, 2002 · Event occurred Jan 21, 2002

Report 2937457-2002-00014 · MDR key 378006

Device

Generic name

Hemodialysis Machine

Model number

2008K

Catalog number

NA

Lot number

NA

Product problems

  • Increase in Pressure
  • Insufficient Flow or Under Infusion
  • Other (for use when an appropriate device code cannot be identified)

Patient

68 YR

  • Low Blood Pressure/ Hypotension
  • Sleep Dysfunction
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

FRESENIUS MEDICAL CARE CANADA, INC. REPORTED THAT THERE WAS EXCESSIVE FLUID REMOVED DURING A HEMODIALYSIS TREATMENT. THE MACHINE GAVE A HIGH ARTERIAL PRESSURE ALARM. THE PT BECAME HYPOTENSIVE 20 MINUTES INTO THE TREATMENT AND WAS GIVEN 200CC OF SALINE. THE NURSE NOTICED THAT THE ULTRA-FILTRATION (UF) RATE WAS HIGHER THAN EXPECTED BASED ON THE UF GOAL AND UF TIME. UF GOAL WAS 600 ML. UF TIME WAS 3:10, ULTRA-FILTRATION RATE WAS 1,630 ML/HR, AND UF REMOVED WAS 568 ML. TREATMENT WAS CONTINUED AND COMPLETED WITH THE UF TURNED OFF. THE PT REC'D ADD'L SALINE DURING TREATMENT. THERE WAS NO SERIOUS INJURY OR ILLNESS.

Remedial action

  • Other