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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE PTE. LTD. COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP 80FRN

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BAXTER HEALTHCARE PTE. LTD. COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP 80FRN Back to Search Results
Catalog Number 2M9163
Event Date 07/30/2007
Event Type  Death  
Manufacturer Narrative

Evaluation of the device indicates the reported condition of fail code 16:310 was confirmed but could not be duplicated during service. The pump passed power on self-test on ac. The front bezel was opened & a visual inspection of all wires, harness connections, and user interface module printed circuit board was performed. The master and slave software programmable read only memory were found inserted correctly. No visual damage was found. The batteries had 10 charge/discharge cycles & 0 discharges below alarm threshold. The pump passed the keypad test. The device has been returned to baxter technical service for repair. The buffer overflow issue resulting in failure code 16:310 found in the software version utilized in colleague infusion pumps has been found to be repeatable in a specific clinical situation, and has resulted in multiple patient adverse events over a short period of time following initiation of deployment of this software version in the us. The issue is caused by an overflow in the memory buffer that feeds the main processor. The c2006 software version includes several changes that have increase the utilization level of this buffer, resulting in a higher probability of overflow. For the version of software utilized in pumps outside of the us (vb), including the one involved in this complaint from another country, the buffer utilization level is significantly lower. The complaint rate for the vb software is approximately 1 complaint per million infusions (cpmi) as compared to a complaint rate of 163 cpmi on the c2006 software. Based on these differences, colleague infusion pumps with the vb software are not considered equivalent to those with the c2006 software.

 
Event Description

The facility reported that the failure code 16:310 occurred on the pump during use on a patient. The pump was infusing propofol 50mcg/kg/min (sedation/anesthetic) and levophed 12mcg/hr (bp) and insulin 2u/hr. All 3 channels failed. The blood pressure of the patient dropped and his icp (intracranial pressure) rose. Medical intervention was required to avoid patient injury. The insulin was increased to 2. 5 u/hr, propofol was decreased to 36 mcg/kg/min and the levophed was increased to 22. 5mcg/hr. The event reportedly occurred between 0800 and 0900 in 2007. The vital signs at 0700 were: bp 172/80, map (mean arterial pressure) 108, p - 80 and icp (intracranial pressure) /cpp (cerebral perfusion pressure) 30/73. At 0830 were: bp 188/80, map 110,9-82. Ay 0900 were: bp 170/74, map 103, p-82, and icp/ccp - 34/70. The patient had in place a right femoral central line, a left radial arterial line, a foley catheter, and a feeding pump. The patient was also on a ventilator. The patient was reportedly unstable and in critical condition. The pump was replaced and the patient was stabilized but considered critical. On the following month, the patient was declared brain dead and expired. The cause of death is listed as brain death. The risk manager is not sure if an autopsy was done. Organs were donated. No litigation is pending at this time.

 
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Brand NameCOLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP
Type of Device80FRN
Manufacturer (Section F)
BAXTER HEALTHCARE PTE. LTD.
SINGAPORE 2573
Manufacturer (Section D)
BAXTER HEALTHCARE PTE. LTD.
SINGAPORE 2573
Manufacturer (Section G)
BAXTER HEALTHCARE PTE. LTD
2 woodlands industrial park d
SINGAPORE 2573
Manufacturer Contact
karen kirby, manager
25212 w. illinois route 120
round lake , IL 60073
(847) 270 -4541
Device Event Key888655
MDR Report Key914443
Event Key876677
Report Number6000001-2007-09468
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 08/08/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2M9163
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/24/2007
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/28/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/04/2007 Patient Sequence Number: 1
Treatment
PAVULON (MUSCLE RELAXANT)
MORPHINE (PAIN) WERE ALSO BEING INFUSION
(CONCENTRATION
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