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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 2429-0500
Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/11/2018
Event Type  malfunction  
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.
 
Event Description
The customer reported tubing for a 500ml bag of normal saline was primed, inserted into the pump module, and infused at 30ml/hour.It was noted that saline was dripping off the bottom of the pump module.The product was found to have a crack just below the upper fitment.The tubing was changed, and there was no patient harm.The customer later reported the set has an expiration date of august 1, 2021.
 
Event Description
The customer reported tubing for a 500ml bag of normal saline was primed, inserted into the pump module, and infused at 30ml/hour.It was noted that saline was dripping off the bottom of the pump module.The product was found to have a crack just below the upper fitment.The tubing was changed, and there was no patient harm.The customer later reported the set has an expiration date of (b)(6), 2021.
 
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Brand Name
ALARIS® PUMP MODULE ADMINISTRATION SET
Type of Device
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8215108
MDR Text Key132065035
Report Number9616066-2018-02647
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403228018
UDI-Public10885403228018
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2021
Device Model Number2429-0500
Device Catalogue Number2429-0500
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100,8015,TD UNK
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