FDA Adverse Event Death Summary report: N

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

MDR report key: 608253 · Received May 27, 2005

Report

Report Number
6000001-2005-01815
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 COLLEAGUE 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 HOSPITAL 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-SPECIFIED MEDICATIONS, AT UNKNOWN AT RATES. IT WAS NOT KNOWN BY THE REPORTING NURSE WHICH MEDICATION WAS BEING INFUSED THROUGH WHICH CHANNEL AND PUMP. THE EVENT OCCURRED AT APPROXIMATELY 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 "BENT" BY THE BLUE SLIDE CLAMP INSIDE THE CHANNEL. IMMEDIATELY, OTHER PUMPS STARTED ALARMING "AIR IN LINE", WITH NO AIR IN THE TUBING SEEN. THE NURSE BELIEVED THE ALARMS ON THE REMAINING PUMPS OCCURRED DUE TO 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 INFUSING DOPAMINE AND LEVOPHED. THE NURSE PRESSED "ADVANCE AIR" ON THE DOPAMINE CHANNEL, AND AS SOON AS 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 STARTED 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 AND LOADING THE DRIPS, WHICH TOOK APPROXIMATELY 20 MINUTES. THE PT'S BLOOD PRESSURE DROPPED TO THE 50'S WITH INCREASED HEART RATE, BUT THE PT DID NOT ARREST. ALL MEDICATIONS WERE RESTARTED. NO ADDITIONAL BOLUSES COULD BE 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 WWAS 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. NO ADDITIONAL INFORMATION AVAILABLE. THIS EVENT WAS ALSO SUBMITTED VIA 30 DAY MEDWATCH # 6000001-2005-01801, #6000001-2005-01812, #6000001-2005-01813, AND #6000001-2005-01814, FOR THE REMAINING (FOUR) PUMPS.

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 NA05

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death