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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION
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CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problems Break (1069); Corroded (1131); Excess Flow or Over-Infusion (1311); No Audible Prompt/Feedback (2282); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Cough (4457)
Event Date 03/14/2023
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the failure investigation has been completed.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
 
Event Description
It was reported that there was an over infusion of gemzar.Fifteen (15) minutes after beginning a secondary infusion of gemzar with a primary infusion of saline, the pump alarmed stating air in line and the line was noted to be empty unexpectedly quickly.After which the pump was stopped and line disconnected from patient, channel removed.A new line was primed and gemzar was restarted using a different channel.After fifteen (15) minutes, patient had complaints of coughing, shortness of breath and chest discomfort.Gemzar was stopped and disconnected, patient was transferred to hospital and appeared to not be in distress upon leaving with emergency medical services.
 
Manufacturer Narrative
Omit : a1402 - excess flow or over-infusion (1311), g04105 - pump, b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.
 
Event Description
It was reported that the device after fifteen (15) minutes of gemzar infusion, the pump had air in line.After which the pump was stopped and line disconnected from patient, channel removed.A new line was primed and gemzar was restarted using a different channel.After fifteen (15) minutes, patient had complaints of coughing, shortness of breath and chest discomfort.Gemzar was stopped and disconnected, patient was transferred to hospital and appeared to not be in distress upon leaving with emergency medical services.
 
Event Description
It was reported that the device after fifteen (15) minutes of gemzar infusion, the pump had air in line.After which the pump was stopped and line disconnected from patient, channel removed.A new line was primed and gemzar was restarted using a different channel.After fifteen (15) minutes, patient had complaints of coughing, shortness of breath and chest discomfort.Gemzar was stopped and disconnected, patient was transferred to hospital and appeared to not be in distress upon leaving with emergency medical services.
 
Manufacturer Narrative
Correction: describe event or problem.Additional information: investigation summary: the reported over infusion was not confirmed or replicated during testing of the source pump module and both received administration sets.¿ using the system requirements documents, the specification for rate accuracy is for +/- 5% error.Testing showed the source pump module passing all times it was tested, see below.¿ rate accuracy testing was performed using the source pump module, the returned pcu and a primed lab administration set.At a rate of 10ml/hr, the device infused for one hour.The actual rate was measured at 9.8ml/hr (-2.03% error).¿ the returned primed administration set (labeled a) was loaded onto the source pump module and the incident infusion rate of 642ml/h was programmed to infuse.After 18 minutes had passed, testing was completed due to the limited capacity of the scale.The actual rate was measured at 630.34ml/hr (-1.82% error).¿ the returned system primed administration set (labeled b) was loaded onto the source pump module and the incident infusion rate of 642ml/h was programmed to infuse.After 18 minutes had passed testing was completed.The actual rate was measured at 621.93ml/hr (-3.13% error).¿ the pcu device was powered on 14 march 2023 at 12:02 pm, the pump module alarmed for flow stop open (4 seconds).It could not be determined from the log review if the flow stop was open outside of the device.¿ at 12:04 pm, the source pump module was programmed a primary infusion of gemcitabine (drug id 263) with a rate of 642ml/h, a vtbi of 321ml and a concentration 8.411mg/ml.After the guardrails alert (concentration over limit) was confirmed the pump module was set to a 5-minute delay.¿ at 12:08 pm, the delay was cancelled, and the infusion was started.¿ at 12:28 pm to 12:30 pm, the pump module alarmed for accumulated air in line and was confirmed by the user.Primary volume infused (pvi) was recorded as 208ml.¿ at 12:31 pm, the pump module alarmed for flow stop open twice and the door was closed.¿ at 12:33 pm, the pump module was selected for programming, a vtbi of 321ml was entered and the infusion was started after the user confirmed the guardrails alert.Pvi was recorded as 208ml.¿ at 12:36 pm, the pump module alarmed for flow stop open, door open, check iv set and the pump module was channeled off.Pvi was recorded as 233.53ml.¿ laboratory testing was performed on both returned administration sets.No anomalies were observed during testing and no backflow was observed.¿ measuring of both administration set¿s pumping segments at bd brea observed the pumping segments to be within specification.¿ inspection of the returned source pump module and administration sets found no anomalies with any of the components.¿ a review of the returned pump module and pcu logs observed no errors or malfunctions on the day of the reported incident.
 
Event Description
It was reported that gemzar was hung and the tubing was connected to another primary line infusing normal saline via different pump.Approximately fifteen minutes into the infusion, the pump reportedly alarmed air-in-line.Upon observation, the line was reportedly found empty "to the end of the tubing." the pump was then stopped, and the line was disconnected from the patient.The patient reportedly appeared to be in no distress immediately after the event.A new line was primed and gemzar was restarted using a different channel.After fifteen (15) minutes, patient reportedly had complaints of coughing, shortness of breath and chest discomfort.Gemzar was stopped and disconnected, patient was transferred to hospital and appeared to not be in distress upon leaving with emergency medical services.
 
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Brand Name
ALARIS SYSTEM
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
brett wilko
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key16705484
MDR Text Key312934715
Report Number2016493-2023-144615
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403810015
UDI-Public(01)10885403810015
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8100
Device Catalogue Number8100 ALARIS LVP MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/17/2023
Initial Date FDA Received04/10/2023
Supplement Dates Manufacturer Received03/17/2023
03/17/2023
03/17/2023
Supplement Dates FDA Received05/23/2023
07/25/2023
11/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
8015.; 8100.
Patient Outcome(s) Required Intervention;
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