inforMED
OtherFLC

FRESENIUS

Received Mar 18, 1994 · Event occurred Nov 17, 1993

Report 2243621-1994-00014 · MDR key 14298

Device

Generic name

Bedside Station Dialysis Machine

Model number

2008 BSS

Product problems

  • Incorrect Measurement
  • Inadequate Ultra Filtration

Patient

72 YR

  • Hemodialysis
  • Low Blood Pressure/ Hypotension

Narrative

Description of Event or Problem

PT DENIED ANY PROBLEMS PRE DIALYSIS. TEMPERATURE NOT DONE. BLOOD PRESSURE 140/80 WEIGHT 138 POUNDS - GAIN 4 LBS. DIALYSIS WAS INITIATED AT 400 BLOOD FLOW-SITE 460CC ULTRAFILTRATION RATE WITH ULTRAFILTRATION GOAL OF 1400CC. ONE HR 55 MIN INTO DIALYSIS PT'S BLOOD PRESSURE DROPPED TO 80/60. PT WAS GIVEN 200CC OF SALINE AND 50CC MANNITOL. THE PT'S BLOOD PRESSURE 35 MIN PRIOR TP THIS WAS 90/70 BUT NO OTHER INTERVENTIONS WERE DONE. AT 2 HRS 20 MINS OF TREATMENT PT WAS GIVEN AN ADDITIONAL 200CC OF SALINE FOR BLOOD PRESSURE 100/70. PT DIALYSIS WAS TERMINATED 10 MIN EARLY BECAUSE SHE FELET SICK. POST DIALYSIS BLOOD PRESSURE 130/70. TEMPERATURE 97.2.