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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS PUMP MODULE; PUMP, INFUSION
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CAREFUSION SD ALARIS PUMP MODULE; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)
Patient Problems Gastritis (1874); Nausea (1970); Vomiting (2144); Toxicity (2333)
Event Date 06/13/2020
Event Type  Injury  
Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
It was reported that a patient was being infused with fluorouracil (500ml of dextrose 5% in water with fluorouracil 3530mg, ordered at a rate of 12.4 ml/hour for a total volume of 570.6ml).It appears to the customer that this was a manual infusion programmed by the nurse.The customer reported this as a "free-flow" event where the infusion completed in 2.5 hours.The patient experienced severe nausea/vomiting.Vistogard was ordered and given to patient for potential toxicity along with observation.The patient was then diagnosed with stomatitis as a result of the over-infusion and continues to be hospitalized as of (b)(6) 2020.
 
Event Description
It was reported that a patient was being infused with fluorouracil (500ml of dextrose 5% in water with fluorouracil 3530mg, ordered at a rate of 12.4 ml/hour for a total volume of 570.6ml).It appears to the customer that this was a manual infusion programmed by the nurse.The customer reported this as a "free-flow" event where the infusion completed in 2.5 hours.The patient experienced severe nausea/vomiting.Vistogard was ordered and given to patient for potential toxicity along with observation.The patient was then diagnosed with stomatitis as a result of the over-infusion and continues to be hospitalized as of (b)(6) 2020.
 
Manufacturer Narrative
Additionl information: regulatory agency ref.Number / medwatch number/info mw5095253;e4.
 
Event Description
It was reported that a patient was being infused with fluorouracil (500ml of dextrose 5% in water with fluorouracil 3530mg, ordered at a rate of 12.4 ml/hour for a total volume of 570.6ml).It appears to the customer that this was a manual infusion programmed by the nurse.The customer reported this as a "free-flow" event where the infusion completed in 2.5 hours.The patient experienced severe nausea/vomiting.Vistogard was ordered and given to patient for potential toxicity along with observation.The patient was then diagnosed with stomatitis as a result of the over-infusion and continues to be hospitalized as of (b)(6) 2020.
 
Event Description
It was reported that a patient was being infused with fluorouracil (500ml of dextrose 5% in water with fluorouracil 3530mg, ordered at a rate of 12.4 ml/hour for a total volume of 570.6ml).It appears to the customer that this was a manual infusion programmed by the nurse.The customer reported this as a "free-flow" event where the infusion completed in 2.5 hours.The patient experienced severe nausea/vomiting.Vistogard was ordered and given to patient for potential toxicity along with observation.The patient was then diagnosed with stomatitis as a result of the over-infusion and continues to be hospitalized as of (b)(6) 2020.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "iv infusion pump was set at 12 4 ml/hr as ordered, but the pump module had an unnoticed physical defect which allowed the 46 hour long infusion to take less than 2 5 hours the patient required an interventional medication to reduce the risk of harm to the patient fda safety report id# (b)(4) bd alaris pump infusion set (b)(6) 2020.".
 
Manufacturer Narrative
Investigation conclusion: the reported issue that an infusion of the drug fluorouracil had ¿free flow¿ event and completed within 2.5 hours could not be confirmed.Log analysis results reviewed a secondary infusion of drugid=352, with a concentration entered as 3530mg/570.6ml, was started at 12:26am on (b)(6) 2020.The rate was set at 12.4ml/h which was below the guardrails soft limit of 22.824ml.The infusion was paused first at 3:02am before being turned off at 3:05am.The cause for the early termination of the infusion could not be ascertained from the log.The total calculated volume infused for drugid=352 was recorded at 32.171ml.No devices or administration sets were returned for investigation.Device inspection: n/a, only logs were provided for investigation root cause analysis: a root cause for the reported over infusion of the drug fluorouracil could not be identified from the information received.Device history review: review of the sn (b)(6) service history record showed the device had a manufacture date of 05mar2014.A review of the device service history record was performed beginning from the date of manufacture to the present date 24nov2020 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.No devices received, log review only.
 
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Brand Name
ALARIS PUMP MODULE
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10242536
MDR Text Key197923169
Report Number2016493-2020-01409
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403810015
UDI-Public10885403810015
Combination Product (y/n)N
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8100
Device Catalogue Number8100
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(2)8100,8015,(3)PRI TUBING, TD (B)(6) 2020.
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient Weight51
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