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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRTAION,INTRAVASCULAR
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CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRTAION,INTRAVASCULAR Back to Search Results
Model Number 10010483
Medical Device Problem Codes Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code No Information (3190)
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.Although requested, patient demographics was not provided.
 
Event or Problem Description
It was reported that upon opening the pump door to remove the set, the syringe adapter tubing separated at the safety clamp.It was noted that normal saline was infusing at the time of the event.Although requested, additional information was not provided.
 
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Brand Name
ALARIS® PUMP MODULE ADMINISTRATION SET
Common Device Name
SET,ADMINISTRTAION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9884967
Report Number9616066-2020-01082
Device Sequence Number2897237
Product Code FPA
UDI-Device Identifier10885403232602
UDI-Public10885403232602
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K934095
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) 02/27/2020
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 Number10010483
Device Catalogue Number10010483
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/26/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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