FDA Adverse Event Death Summary report: N

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

MDR report key: 608326 · Received May 27, 2005

Report

Report Number
6000002-2005-01814
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 PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN ACUTE MI (MYOCARDIAL INFARCTION). THE PATIENT WAS IN A VERY CRITICAL CONDITION AND REPORTEDLY HAD CODED SOMETIME PRIOR TO THE EVENT. THE PATIENT WAS ON A BALLOON PUMP AND VENTILATOR, PARALYZED AND SEDATED. THE PATIENT HAD A PERIOPHERAL IV LINE, MULTIPLE CENTRAL LINES, AND A SWAN CATHETER. THE PATIENT'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 PATIENT WAS RECEIVING LEVOPHED, DOPAMINE, VERSED, MORPHINE, NIMBEX, AMNIODORONE, LASIX, "SOME SECONDARY LINES WITH ANTIBIOTIC", AND OTHER ADDITIONAL NON-SPECIFIED 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 APPROXIMATELY 1400 - 1500. THE PATIENT 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 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 PATIENBT'S TRANSFER. THE NURSE STARTED CLEARING THE "AIR IN LINE" ALARM BY USING THE "ADVANCE AIR" FUNCTION ON THE PUMP INFUSING DOPARMINE AND LEVOPHED. THE NURSE PRESSED "ADVANCE AIR" ON THE DOPAMINE CHANNEL, AND AS SOON AS THE PUMP INDICATED "WENT TO FLUID", 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 PATIENT WITHOUT THE PRESSORS. THE NURSE THEN WORKED ON THE REMAINING PUMPS, UNLOADING AND LOADING THE DRIPS, WHICH TOOK APPROXIMATELY 20 MINUTES. THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 50'S WITH INCREASED HEART RATE, BUT THE PATIENT DID NOT ARREST. ALL MEDICATIONS WERE RESTARTED. NO ADDITIONAL BULUSES COULD BE ADMINISTERED DUE TO THE PATIENT BEING TACHYCARDIC. THE NURSE STATED, "NOTHING ELSE COULD HAVE BEEN DONE" BESIDES RESTARTING THE DRIPS. THE PATIENT'S BLOOD PRESSURE CAME BACK UP TO THE 90'S WITHIN 5 MINUTES. LATER THAT DAY, THE PATIENT CODED AND EXPIRED AT 2300. THE NURSE DID NOT BELIEVE THE EVENT WAS DIRECTLY RELATED TO THE PATIENT'S DEATH BUT STATED, "IT DID NOT HELP". ACCORDING TO THE NURSE, AN AUTOPSY WAS NOT PERFORMED. THE NURSE REPORTED THE CAUSE OF THE PATIENT'S DEATH WAS DETERMINED TO BE CARDIOGENIC SHOCK. THE DEATH CERTIFICATE WAS REQUESTED BY BAXTER FROM THE FACILITY, HOWEVER IT WAS NOT MADE AVAILABLE. THE EVENT WAS ALSO SUBMITTED VIA 30 DAY MEDWATCH #6000001-2005-1801, #6000001-2005-01812, #6000001-2005-01813, AND #6000001-2005-01815 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 NA04

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death