inforMED
DeathFPA

MICROCLAVE

Received Apr 11, 2013 · Event occurred Dec 5, 2012

Report 3067726 · MDR key 3067726

Device

Generic name

Set, Administration, Intravascular

Manufacturer

Icu Medical, Inc.

Model number

*

Catalog number

*

Lot number

18-841-SJ

Product problems

  • Disconnection
  • Fluid/Blood Leak
  • Device Displays Incorrect Message

Patient

46 YR

  • Low Blood Pressure/ Hypotension
  • Blood Loss
  • Test Result

Narrative

Description of Event or Problem

PATIENT FOUND IN BED LYING IN A POOL OF BLOOD MIXED WITH IV FLUID. BLUE PART OF IV HUB HAD BECOME DISCONNECTED DURING THE NIGHT. STAFF ALERTED BY BLOOD PRESSURE ALARM WHICH NOTED DROP TO 64/44. STAT CBC GAVE HGB AS 6.4 (DROPPED FROM 10.9 TWO HOURS EARLIER). PATIENT TRANSFUSED & MEDS/FLUIDS GIVEN TO INCREASE BP.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PROVISION OF IV FLUIDS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.