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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 11059728
Medical Device Problem Codes Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Information (3190)
Date of Event 06/13/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Patient demographics requested however not provided.
 
Event or Problem Description
It was reported by the anesthesiologist that when tightening the connection on a gravity set with stopcocks-manifold it caused a crack in the hub and leaked.
 
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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 Key8838108
Report Number9616066-2019-02055
Device Sequence Number14081882
Product Code FPA
UDI-Device Identifier10885403234644
UDI-Public10885403234644
Combination Product (Y/N)N
Initial Reporter StateAK
Initial Reporter CountryUS
PMA/510(K) Number
K931173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/03/2019
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 Model Number11059728
Device Catalogue Number11059728
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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