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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS PUMP ADMINISTRATION SET SET,ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2421-0500
Device Problem Insufficient Information (3190)
Patient Problems Apnea (1720); Cardiopulmonary Arrest (1765)
Event Type  Injury  
Manufacturer Narrative
Patient was an infant - preemie. An incomplete date of event of (b)(6) 2019 was provided in medwatch. Although requested, product has not been received. A follow up report will be submitted with failure investigation results should the product be received for evaluation. Concomitant medical products: lot 18018388 is not a valid lot number.
 
Event Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "infant went apneic. No response to stimulation. Intubated. See code sheet for times and medications given per dr. Per code emergency drug sheet at bedside. " an incomplete date of event of (b)(6) 2019 was provided. Although requested, no further details were provided by the customer for this event.
 
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Brand NameALARIS PUMP 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
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9290577
MDR Text Key165438894
Report Number9616066-2019-03167
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 health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model Number2421-0500
Device Catalogue Number2421-0500
Device Lot Number18018388
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/31/2018
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: 11/07/2019 Patient Sequence Number: 1
Treatment
82113E, 20028E, 8100, 8015, THERAPY DATE UNKNOWN
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