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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS SECONDARY ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MS3500-15
Device Problem Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2019
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
It was reported that when amiodarone ivpb was priming the secondary iv tubing fell apart from the spike. Patient impact or delay was not reported.
 
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Brand NameALARIS SECONDARY 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 Key9497745
MDR Text Key177012373
Report Number9616066-2019-03711
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403222610
UDI-Public10885403222610
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/12/2021
Device Model NumberMS3500-15
Device Catalogue NumberMS3500-15
Device Lot Number18115872
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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