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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PC UNIT; PUMP, INFUSION
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CAREFUSION ALARIS PC UNIT; PUMP, INFUSION Back to Search Results
Model Number 8015
Device Problems Low Battery (2584); Battery Problem (2885); Power Problem (3010)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 12/27/2017
Event Type  Death  
Manufacturer Narrative
The affected device has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
The customer reported that the pcu alarmed with a message that the device needed to be plugged in or it would shut off.The pcu was plugged in and then the screen turned red and stated ¿battery discharge.¿ the user was only able to shut the pcu down and restart it.Levophed 4mg/250ml at 1mcg/kg/hr and neosynephrine 8mg/50ml at 3mcg/kg/hr were infusing; the patient coded due to this event.The pcu was switched out and the same thing happened again; both devices were sequestered.Biomed checked the battery capacity using maintenance software and found it to be 774 milliamp hours.Battery conditioning was performed.The patient was revived following the code, but later passed away.
 
Manufacturer Narrative
Conclusion code: no available code for undetermined or unknown cause.Although the customer initially reported a patient weight of (b)(6) , both (b)(6) were used during programming.The customer¿s report of a pump battery discharge was confirmed.Analysis of the pcu event log shows that the system was powered on at 6:43 am on (b)(6) 2017 while on ac power.Four pump modules were attached to pcu s/n (b)(4) and infusing fentanyl, vasopressin, phenylephrine, and norepinephrine non ct.At 1:26 pm the system was switched to dc power and remained on battery power for approximately 4 hours and 12 minutes until 5:38 pm when the pcu alarmed for battery discharged and all 4 pump modules were paused.The user then selected softkey 14 (system off) to address the battery discharged pop-up and the system was powered off.It cannot be determined whether battery conditioning had been performed since the battery log only included data for (b)(6) 2017 to (b)(6) 2018.The log contained no conditioning events during those 3 months.The pcu having missed both low battery (lb1) and very low battery (lb2) alarms can be attributed to the battery nearing the end of its life expectancy.The battery had a date code indicating approximately the last week of (b)(6) 2016.It is recommended that batteries be replaced every 2 years and conditioned every 12 months.Frequent use of battery power and insufficient battery charging may decrease battery life, which may result in missing low battery alarms.The cause of the battery discharge is an inadequate charge capacity.
 
Event Description
Received a copy of the customer's medwatch report from the (b)(6) which states: "iv pump malfunction.Pump alarmed - told us to plug it in or it would turn off.The pump was plugged in.Then the screen turned red and stated "battery discharge".The only thing it allowed me to do was shut the pump down and restart.This pump was running levo at 1 mcg/kg/hr, and neo at 3 mcg/kg/hr.".
 
Manufacturer Narrative
Physical inspection noted the device to be in fair condition with the instrument seal intact.Both iui connectors were observed to be dull.No other anomalies were observed.The root cause of the customer¿s report of battery discharge was identified as accelerated battery aging/wear due to extreme battery usage and not recommended charging practices.
 
Event Description
The customer reported that the pcu alarmed with a message that the device needed to be plugged in or it would shut off.The pcu was plugged in and then the screen turned red and stated ¿battery discharge.¿ the user was only able to shut the pcu down and restart it.Levophed 4mg/250ml at 1mcg/kg/hr and neosynephrine 8mg/50ml at 3mcg/kg/hr were infusing; the patient coded due to this event.The pcu was switched out and the same thing happened again; both devices were sequestered.Biomed checked the battery capacity using maintenance software and found it to be 774 milliamp hours.Battery conditioning was performed.The patient was revived following the code, but later passed away.Received a copy of the customer's medwatch report from the fda which states: "iv pump malfunction.Pump alarmed-told us to plug it in or it would turn off.The pump was plugged in.Then the screen turned red and stated "battery discharge".The only thing it allowed me to do was shut the pump down and restart.This pump was running levo at 1mcg/kg/hr, and neo at 3mcg/kg/hr.".
 
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Brand Name
ALARIS PC UNIT
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7222966
MDR Text Key98402648
Report Number2016493-2018-00086
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K950419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 01/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8015
Device Catalogue Number8015
Other Device ID Number10885403801518
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age45 YR
Patient Weight74
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