inforMED
MalfunctionCAR

CAREFUSION

Received Dec 2, 2015 · Event occurred Nov 25, 2015

Report MW5058355 · MDR key 5273167

Device

Generic name

Primary Iv Pump Tubing For Chemo

Manufacturer

Carefusion

Catalog number

10015862

Lot number

NA

Product problems

  • Fluid/Blood Leak
  • Chemical Spillage

Patient

10 YR

  • Chemical Exposure

Narrative

Description of Event or Problem

VINCRISTINE WAS BEING ADMINISTERED IN THE OUTPATIENT PEDIATRIC INFUSION CENTER AT A RATE OF 900ML/HR TO INFUSE OVER 5 MINUTES VIA PRIMARY CHEMO TUBING VIA AN ALARIS PCU AND LARGE VOLUME MODULE. TREATMENT OF ACUTE LEUKEMIA (ALL) IN REMISSION. THE PATIENT STATED THAT HE FELT SOMETHING DRIPPING. WHEN INVESTIGATING THE TUBING IT WAS FOUND TO HAVE A LEAK AT THE DRIP CHAMBER ABOVE THE PUMP. DUE TO THE NATURE OF THE VESICANT BEING ADMINISTERED, CHEMO PRECAUTIONS AND SPILL MANAGEMENT BEGAN INCLUDING WASHING THE PATIENT'S SKIN WITH SOAP AND WATER FOR 10-15 MINUTES AND REMOVAL AND DISPOSAL OF HIS SOCK AS THERE WERE TRACES OF THE MEDICATION ON IT AS WELL. NO FURTHER MEDICATION OR INTERVENTIONS MADE. RECURRING EVENT OVER TIME. ONE TIME USE FOR THIS EVENT.