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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS INFUSION SET SET, INFUSION, INTRAVASCULAR

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CAREFUSION ALARIS INFUSION SET SET, INFUSION, INTRAVASCULAR Back to Search Results
Model Number 10015862
Device Problem Fluid Leak (1250)
Patient Problem Burning Sensation (2146)
Event Date 12/03/2018
Event Type  Injury  
Manufacturer Narrative
No product will be returned per customer. The customer complaint could not be confirmed because the product was not returned for failure investigation. The root cause of this failure was not identified.
 
Event Description
The customer reported that the tubing spike which was in a 1000ml bag of etoposide, doxorubicin, and vincristine (vesicants) had dislodged from the bag and spilled on the nurse. The short primary tubing was connected very close to the pump. The nurse reported that she felt as if her skin was burning, similar to a sunburn, as a result of the chemo spilling on her. The area did not blister and she did not see a physician. The customer stated that no medical intervention was required.
 
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Brand NameALARIS INFUSION SET
Type of DeviceSET, INFUSION, 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 Key8199541
MDR Text Key131504768
Report Number9616066-2018-02591
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10015862
Device Catalogue Number10015862
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 12/27/2018 Patient Sequence Number: 1
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