inforMED
MalfunctionFIN

BIPRO SYSTEMS SDS CB200

Received Jun 14, 2017 · Event occurred Jun 7, 2017

Report MW5070418 · MDR key 6643186

Device

Generic name

Mixing And Distribution System Of Bicarbonate For Dialysis

Manufacturer

Medical Solution

Model number

SDS CB200

Product problems

  • Device Operates Differently Than Expected

Patient

Not reported

  • Low Blood Pressure/ Hypotension
  • Nausea
  • Vomiting
  • Low Blood Pressure/ Hypotension
  • Nausea
  • Vomiting

Narrative

Description of Event or Problem

HEMODIALYSIS PTS C/O NAUSEA, VOMIT, HYPOTENSION IN BETWEEN CHANGE OVER OF 1ST AND 2ND SHIFT 10:00 AM - 12:00PM. STAFF IDENTIFIED BICARB TANK. MALFUNCTION IN WHICH BICARB IN DAY TANK WAS DILUTED, BICARB CONDUCTIVITY OUT OF RANGE, INDICATING DILUTION.

Description of Event or Problem

HEMODIALYSIS PTS C/O NAUSEA, VOMIT, HYPOTENSION IN BETWEEN CHANGE OVER OF 1ST AND 2ND SHIFT 10:00 AM - 12:00PM. STAFF IDENTIFIED BICARB TANK. MALFUNCTION IN WHICH BICARB IN DAY TANK WAS DILUTED, BICARB CONDUCTIVITY OUT OF RANGE, INDICATING DILUTION.

Description of Event or Problem

HEMODIALYSIS PTS C/O NAUSEA, VOMIT, HYPOTENSION IN BETWEEN CHANGE OVER OF 1ST AND 2ND SHIFT 10:00 AM - 12:00PM. STAFF IDENTIFIED BICARB TANK. MALFUNCTION IN WHICH BICARB IN DAY TANK WAS DILUTED, BICARB CONDUCTIVITY OUT OF RANGE, INDICATING DILUTION.

Description of Event or Problem

HEMODIALYSIS PTS C/O NAUSEA, VOMIT, HYPOTENSION IN BETWEEN CHANGE OVER OF 1ST AND 2ND SHIFT 10:00 AM - 12:00PM. STAFF IDENTIFIED BICARB TANK. MALFUNCTION IN WHICH BICARB IN DAY TANK WAS DILUTED, BICARB CONDUCTIVITY OUT OF RANGE, INDICATING DILUTION.