FDA Adverse Event Other Summary report: N

1000ML EVACUATED CONTAINER

MDR report key: 973543 · Received December 20, 2006

Report

Report Number
973543
Event Type
Other
Date Received
December 20, 2006
Date of Event
November 29, 2006
Report Date
December 1, 2006
Manufacturer
HOSPIRA INC.
Product Code
KPE
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

TITLE: EVACUATED CONTAINER. THE PT ARRIVED TO THE OUTPATIENT INFUSION ROOM FOR A 500ML THERAPEUTIC PHLEBOTOMY. A 16 GAUGE CATHETER WAS INSERTED IN THE LEFT BASILIC VEIN. THE CATHETER WAS THEN CONNECTED TO THE VACUUM COLLECTION TUBING. THE TUBING NEEDLE WAS THEN INSERTED INTO THE VACUTAINER BOTTLE AND THE TUBING WAS UNCLAMPED. THE BLOOD WAS DRAINING INTO THE BOTTLE IN A STEADY STREAM THE FLOW DECREASED TO A DRIP. THE TOURNIQUET PREVIOUSLY PLACED ON THE PTS ARM WAS LOOSENED. IMMEDIATELY THE BLOOD IN THE TUBING BACKED UP TO THE PT AND WAS MAKING A GURGLING NOISE AT THE INSERTION SITE. THE TOURNIQUET WAS REAPPLIED TO THE PATIENTS ARM AND THE BLOOD IMMEDIATELY BEGAN TO FLOW IN A STREAM BACK INTO THE BOTTLE. THE TUBING WAS THEN CLAMPED. PATIENT THEN STATED "I FEEL LIKE THE AIR WENT INTO MY VEINS. MY CHEST FEELS LIKE THERE IS LOT OF PRESSURE ON IT." THE PT COUGHED A FEW DRY COUGHS AND WAS LOWERED INTO A RECLINING POSITION. THE PT THEN STATED, "I FEEL FUNNY, NOT DIZZY, THERE IS JUST PRESSURE IN MY CHEST." THE PT WAS PALE, ANXIOUS, AND SLIGHTLY DIAPHORETIC. THE PT WAS IMMEDIATELY TAKEN TO CT WITH ER DR PRESENT. TECHNICIAN RETURNED TO THE ROOM AND RETRIEVED THE BOTTLE USED WITH ABOUT 250ML OF BLOOD IN THE BOTTLE. THE BOTTLE WAS UNCLAMPED AND THE TUBING WAS WITNESSED BY TWO RN'S TO BE UNDER PRESSURE, SPURTING BLOOD FROM THE TUBING TO THE FLOOR. TYPICALLY THERE IS A VACUUM EFFECT THAT WOULD SUCK THE BLOOD, NEVER EXPEL IT FROM THE SYSTEM. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 1000ML EVACUATED CONTAINER CONTAINER KPE HOSPIRA INC. * 46-P16-DM-01

Patients

Seq Age Sex Outcome Treatment
1 57 YR Other