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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2429-0500
Device Problems Fluid Leak (1250); Material Separation (1562)
Patient Problem Death (1802)
Event Date 01/05/2017
Event Type  Death  
Manufacturer Narrative
Customer medwatch number: medwatch (b)(4). (b)(4). No product will be returned per customer. The root cause of this failure was not identified.
 
Event Description
The customer reported that while resuscitating a patient with multiple iv pushes and boluses, there was a loud pop sound and then iv fluids were observed to be leaking onto the floor. Upon inspection the customer identified that the tubing separated from the upper fitment. The patient was critically ill with a poor prognosis and expired a short time later. The customer stated that the death was not believed to have been related to the leak. Received a copy of the customer's medwatch report from fda, which states ¿during coding of the patient, numerous iv pushes and boluses were being given. At some point, there was a loud pop (sound) in the room and iv fluids ware seen running onto the floor. Upon identifying where the tubing came from, it was discovered that the tubing had split away at the point of insertion into the alaris pump (i. E. The blue end that comes out of the top of the alaris pump had split/ separated from the stretchy opaque tubing that sits inside of the pump). ".
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6301123
MDR Text Key66508407
Report Number9616066-2017-00121
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
Report Date 01/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2019
Device Model Number2429-0500
Device Catalogue Number2429-0500
Device Lot Number16107305
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/25/2016
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: 02/03/2017 Patient Sequence Number: 1
Treatment
8015,8100, THERAPY DATE (B)(4) 2017
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