FDA Adverse Event Death Summary report: N

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

MDR report key: 608332 · Received May 27, 2005

Report

Report Number
6000001-2005-01812
Event Type
Death
Date Received
May 27, 2005
Date of Event
May 1, 2005
Report Date
May 10, 2005
Manufacturer
BAXTER HEALTHCARE PTE.LTD.
Product Code
FRN
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
AZ, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THE FACILITY'S NURSE REPORTED THAT FIVE COLLEAUGUE INFUSION PUMPS ALARMED "AIR IN LINE", WHEN THERE WAS NO AIR IN THE TUBING, WHILE DELIVERING BLOOD PRESSURE MEDICATIONS. THE PT WAS ADMITTED TO THE HOSP WITH AN ACUTE MI (MYOCARDIAL INFARCTION). THE PT WAS IN A VERY CRITICAL CONDITION AND REPORTEDLY HAD CODED SOMETIME PRIOR TO THE EVENT. THE PT WAS ON A BALLOON PUMP AND VENTILATOR, PARALYZED AND SEDATED. THE PT HAD A PERIPHERAL IV LINE, MULTIPLE CENTRAL LINES, AND A SWAN CATHETER. THE PT'S BLOOD PRESSURE WAS REPORTED TO BE IN THE 90'S, WITH BLOOD PRESSURE MEDICATION SUPPORTING PRIOR TO THE EVENT. FIVE TRIPLE CHANNEL COLLEAGUE PUMPS WERE REPORTED TO BE USED FOR INFUSIONS OF 14 DRIPS. THE PT WAS RECEIVING LEVOPHED, DOPAMINE, VERSED, MORPHINE, NIMBEX, AMNIODORONE, LASIX, "SOME SECONDARY LINES WITH ANTIBIOTIC", AND OTHER ADDITIONAL NON-SPECIFIC MEDIATIONS, AT UNKNOWN RATES. IT WAS NOT KNOWN BY THE REPORTING NURSE WHICH MEDICATION WAS BEING INFUSED THROUGH WHICH CHANNEL AND PUMP. THE EVENT OCCURRED AT APPROX 1400-1500. THE PT WAS BEING TRANSFERRED FROM BED TO BED WHEN A PUMP STARTED ALARMING "AIR IN LINE", BUT THERE WAS NO AIR IN THE TUBING. IT WAS REPORTED THAT THE TUBING WAS "BENT" BY THE BLUE SLIDE CLAMP INSIDE THE CHANNEL. IMMEDIATELY, OTHER PUMPS OCCURRED DUE TO THE IV TUBING BEING STRETCHED AND TIGHTENED DURING THE PT'S TRANSFER. THE NURSE STARTED CLEARING THE "AIR IN LINE" ALARM BY USING THE " ADVANCE AIR" FUNCTION ON THE PUMP INDICATED "WENT TO FLUID", THE NURSE STARTED THE DOPAMINE INFUSION. THE NURSE THEN STARTED TO DO THE SAME ON THE CHANNEL INFUSING LEVOPHED. AT THAT TIME, THE DOPAMINE CHANNEL STARTED ALARMING "AIR IN LINE", FOLLOWED BY THE SAME ALARM ON THE LEVOPHED CHANNEL. THE NURSE UNLOADED THE DOPAMINE AND LEVOPHED TUBING FROM THE CHANNELS, RELOADED THE TUBING, AND RESTARTED THE INFUSIONS. THE PROCESS WAS REPORTED TO TAKE 2-3 MINUTES, LEAVING THE PT WITHOUT THE PRESSORS. THE NURSE THEN WORKED ON THE REMAINING PUMPS, UNLOADING THE DRIPS, WHICH TOOK APPROX 20 MINUTES. THE PT'S BLOOD PRESSURE DROPPED TO THE 50'S ADMINISTERED DUE TO THE PT BEING TACHYCARDIC. THE NURSE STATED, "NOTHING ELSE COULD HAVE BEEN DONE " BESIDES RESTARTING THE DRIPS. THE PT'S BLOOD PRESSURE CAME BACK UP TO THE 90'S WITHIN 5 MINUTES. LATER THAT DAY, THE PT CODED AND EXPIRED AT 2300. THE NURSE DID NOT BELIEVE THE EVENT WAS DIRECTLY RELATED TO THE PT'S DEATH BUT STATED, "IT DID NOT HELP". ACCORDING TO THE NURSE, AN AUTOPSY WAS NOT PERFORMED. THE NURSE REPORTED THE CAUSE OF THE PT'S DEATH WAS DETERMINED TO BE CARDIOGENIC SHOCK. THE DEATH CERTIFICATE WAS REQUESTED BY BAXTER FROM THE FACILITY, HOWEVER IT WAS NOT MADE AVAILABLE. THIS EVENT WAS ALSO SUBMITTED VIA 30 DAY MEDWATCH #6000001-2005-01801, #6000001-2005-01813, #6000001-2005-01814, AND #6000001-2005-01815 FOR THE REMAINING (FOUR) PURPOSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE.LTD. COLLEAGUE 3CX NA02

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death