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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 2430-0500
Medical Device Problem Codes Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/25/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that the tubing set had a hole and leaked from the silicone segment during a carboplatin infusion.The customer later stated that there were no adverse effects caused to the patient from the event.
 
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Brand Name
ALARIS® PUMP MODULE ADMINISTRATION SET
Common Device Name
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8909492
Report Number9616066-2019-02290
Device Sequence Number19234091
Product Code FPA
UDI-Device Identifier07613203011396
UDI-Public7613203011396
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K944320
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) 07/24/2019
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 Date05/27/2022
Device Model Number2430-0500
Device Catalogue Number2430-0500
Device Lot Number19056843
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
8100, 8015, TD (B)(6) 2019
Patient Age49 YR
Patient Weight52
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