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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS SYRINGE MODULE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10014914
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem Underdose (2542)
Event Date 02/13/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: (2) used ganged stopcocks (unspecified manufacturer) and (1) used non-bd set; 10ml covidien syringe; td (b)(6) 2020. The devices have been received and the evaluation is pending. A follow up report will be submitted with investigation results once the evaluation has been completed. Although requested, no patient information provided.
 
Event Description
It was reported that the there was a maxzero crack and leak. The event occurred in the cvicu. Per the reporter, "blood back up in white cvl lumen- into train. " a crack was found which resulted in a precedex leak. The patient did not receive full dose of precedex and milrinone as a result.
 
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Brand NameALARIS SYRINGE MODULE
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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9852963
MDR Text Key192186466
Report Number9616066-2020-00824
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K811885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10014914
Device Catalogue Number10014914
Device Lot Number19087377
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2019
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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