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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 PRI TUBING
Device Problems Reflux within Device (1522); Infusion or Flow Problem (2964)
Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer reported that an secondary of zyvox infused at a rapid rate (assumed, not observed).A subsequent secondary was started and backflow from the secondary into the primary was observed.No patient harm reported.
 
Manufacturer Narrative
No product will be returned.No investigation was performed.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, 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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key4662249
MDR Text Key5604397
Report Number9616066-2015-00429
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/22/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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