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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 20028E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2015
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical product: 500ml ns bag, therapy date: (b)(6) 2015.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
 
Event Description
The customer reported chemo leak at the filter.Patient receiving doxorubicin 16 mg/ m2, etoposide 80 mg/ m2 and vincristine 0.4 mg/ m2 in 500 ml ns bag for 24 hour.Patient noticed orange dots on sheets.No harm to patient reported.Event occurred on med surg floor.
 
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Brand Name
ALARIS EXTENSION SET
Type of Device
SET, EXTENSION, 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 Key5345901
MDR Text Key35109818
Report Number9616066-2016-00031
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K801614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 12/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20028E
Device Catalogue Number20028E
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
(B)(4), PRI TUBING, TD: (B)(6) 2015
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