FDA.reportPublic FDA data

MAUDE MDR 5273167

MDR report key
5273167
Report number
MW5058355
Event key
0
Event type
3
Date of event
2015-11-25
Date received
2015-12-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CAREFUSIONPRIMARY IV PUMP TUBING FOR CHEMOCAREFUSIONCAR10015862NA* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-020

Event Narratives#

D

Patient 1

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.