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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION
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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number 10013889
Medical Device Problem Codes Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned as customer is unknown.No investigation was performed.
 
Event or Problem Description
Received a copy of the customer's sus voluntary event report from cdrh which states, ¿bd alaris pump infusion set, low sorbing tubing: lot number: 17105562.Expiration 10/05/2020, reference number (b)(4).Tubing came apart at pumping segment and avastin was spilled in the hem/onc patient room".
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Common Device Name
SET, ADMINISTRATION, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8757932
Report Number9616066-2019-01793
Device Sequence Number1680870
Product Code FPA
UDI-Device Identifier10885403232282
UDI-Public10885403232282
Combination Product (Y/N)N
Initial Reporter StateCA
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/10/2019
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 Date10/04/2020
Device Model Number10013889
Device Catalogue Number10013889
Device Lot Number17105562
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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