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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 Problems Material Separation (1562); Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: one used 250ml icu medical bag, lot: 04-103-jt, exp: 1 apr 2021, 0. 9% sodium chloride injection. The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed.
 
Event Description
It was reported that the set fell apart at the spike.
 
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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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9460987
MDR Text Key190767464
Report Number9616066-2019-03640
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
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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