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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 2420-0500
Device Problem Stretched (1601)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
It was reported that an incident over the weekend involving the alaris pump, lvp module, and primary infusion set.The primary set was infusing tpn and was hooked to a triple leg extension set that had lipids going to another leg (they were off and clamped at the time), and had an open leg that was being used for intermittent meds.The tpn infusion was placed on a delay and the extension set leg that had the tpn was clamped so the nurse could push albumin to the patient through the open leg.When she went to restart the infusion after pushing the med, she noticed the door of the pump looked slightly ajar.
 
Manufacturer Narrative
No product will be returned.The customer¿s report of that the tubing ballooned was confirmed per customer-provided photo.Photo provided by the customer shows a balloon/bulge in the silicone segment tubing near the upper fitment.The root cause for the source of the excessive pressure is unknown.
 
Event Description
It was reported that an incident over the weekend involving the alaris pump, lvp module, and primary infusion set.The primary set was infusing tpn and was hooked to a triple leg extension set that had lipids going to another leg (they were off and clamped at the time), and had an open leg that was being used for intermittent meds.The tpn infusion was placed on a delay and the extension set leg that had the tpn was clamped so the nurse could push albumin to the patient through the open leg.When she went to restart the infusion after pushing the med, she noticed the door of the pump looked slightly ajar.Although requested, there has been no impact to patient response or additional event information made available to date.
 
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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 Key9548057
MDR Text Key191987561
Report Number9616066-2020-00021
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012430
UDI-Public7613203012430
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 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2420-0500
Device Catalogue Number2420-0500
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100,8015, THERAPY DATE UNK.
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