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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 10013361T
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The photo provided by the customer shows the tubing ballooned and collapsed the silicone segment.The root cause of this failure was not identified.
 
Event or Problem Description
The customer reported that the tubing ballooned and collapsed in the pump and created a blood return from the patient.There was no patient harm.
 
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Brand Name
ALARIS INFUSION SET
Common Device Name
SET, INFUSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8140348
Report Number9616066-2018-02428
Device Sequence Number1553331
Product Code FPA
UDI-Device Identifier10885403223204
UDI-Public10885403223204
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K053049
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/13/2021
Device Model Number10013361T
Device Catalogue Number10013361T
Device Lot Number18035178
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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