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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE; PUMP, INFUSION
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CAREFUSION ALARIS PUMP MODULE; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problem Fail-Safe Problem (2936)
Patient Problem No Information (3190)
Event Date 07/22/2019
Event Type  malfunction  
Manufacturer Narrative
The event logs have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.No device received-log review only.
 
Event Description
It was reported that there was a programming event during a propofol infusion, however it is unknown whether it was an under infusion or an over infusion event.The customer is asking for the investigation to determine whether the propofol was infusing through the device and whether there were any alarms within the event timeframe.It was later reported that there is suspicion of rn drug diversion.The rn stated that she manipulated the tubing set due to the device alarming.The customer would like to know the following: was propofol infusing via the pump, were there any alarms in the documented timeframe?.
 
Manufacturer Narrative
Review of the returned pcu event logs could not confirm any propofol infusions on the reported event date of (b)(6) 2019 between 4:30 am ¿ 5:45 am.The drug id¿s associated with propofol were reviewed and no programming using these drug id¿s were found in the logs.There were no alarms observed in the logs during the documented timeframe.No devices or administration sets were returned for investigation so no testing could be performed.The first infusion on the reported event date was programmed using pump module (s/n 13513756) beginning at 7:22 am as drug id 472 (potassium chloride) and began infusing at a rate of 50ml/hr with a vtbi of 100ml.During this infusion a patient side occlusion alarm occurred a short time after the infusion was started.The pcu event logs were reviewed in their entirety from 7/23/2019 at 8:29:15 pm to 8/7/2019 at 2:51:06 pm.The source device pump module (s/n (b)(4)) was not attached to the pcu until after the reported event.The logs show that the source device was attached as channel d on 7/28/2019 at 3:21:32 pm.The first entry in the returned logs was recorded on 07/23/2019 at 8:29 pm.The infusion was programmed using pump module (s/n (b)(4)) at a concentration of 1000mg/100ml and a patient weight of 58.8kg.The unknown drug began infusing at a rate of 14.112ml/hr with a vtbi of 53ml.The drug id for this infusion could not be determined because the programming occurred prior to where the log begins.N/a, the customer requested an investigation to determine whether propofol was infusing through the device and whether there were any alarms within the event time frame.Device evaluated by mfr: no device received-log review only.
 
Event Description
It was reported that there was a programming event during a propofol infusion, however it is unknown whether it was an under infusion or an over infusion event.The customer is asking for the investigation to determine whether the propofol was infusing through the device and whether there were any alarms within the event timeframe.It was later reported that there is suspicion of rn drug diversion.The rn stated that she manipulated the tubing set due to the device alarming.The customer would like to know the following: was propofol infusing via the pump, were there any alarms in the documented timeframe?.
 
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Brand Name
ALARIS PUMP MODULE
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8967156
MDR Text Key172456407
Report Number2016493-2019-01142
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403222054
UDI-Public10885403222054
Combination Product (y/n)N
PMA/PMN Number
K950419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? No
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)8015(4)PRI TUBING,(3)8100,TD (B)(6) 2019
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