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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number 2426-0500
Device Problem Material Deformation (2976)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 02/04/2020
Event Type  Death  
Manufacturer Narrative
The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
It was reported that tubing model #2426-0500 failed during a code. A patient was admitted to the emergency department [ed] requiring cpr compressions and was coded multiple times throughout the day. An epinephrine drip infusing at 20mcg/kg/min stopped working after 10 minutes of use and the pump started alarming. The pump was opened and the tubing appeared dilated [ballooning] between the blue connector and the safety clamp. This lead to a 15-20 second delay in care while the tubing was changed out to prime a new epinephrine drip. The epinephrine was infusing through a central line. The patient expired on (b)(6) 2020. The primary cause of death was cardiac arrest and no autopsy will be performed. The medical center stated, "the patient's death was already happening, the event was a tiny piece of that puzzle. It is unlikely the event contributed to the patient's death. ".
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, 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
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9750683
MDR Text Key180751083
Report Number9616066-2020-00567
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0500
Device Catalogue Number2426-0500
Device Lot Number19123168
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2020 Patient Sequence Number: 1
Treatment
8100, 8015, THERAPY DATE UNKNOWN
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