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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 10012144
Medical Device Problem Codes Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Blood Loss (2597)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event or Problem Description
It was reported that during a calcium gluconate infusion for a patient receiving dialysis, the tubing leaked at the needleless port closest to the patient resulting in blood backing up into the tubing.Fluid and blood leaked out of the needleless port into the floor over an hour.The patient became hypocalcemic, symptomatic, with a small amount of blood loss.No other patient effects were reported.
 
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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 Key8796203
Report Number9616066-2019-01917
Device Sequence Number2638968
Product Code FPA
UDI-Device Identifier07613203021159
UDI-Public7613203021159
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K944320
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/18/2021
Device Model Number10012144
Device Catalogue Number10012144
Device Lot Number18076961
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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