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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 2420-0007
Device Problem Material Deformation (2976)
Patient Problem No Information (3190)
Event Date 04/01/2020
Event Type  malfunction  
Manufacturer Narrative
Although requested no information at this time provided.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
It was reported that tubing by the nurse that the pump alarmed "distal occlusion".The nurse attempted to flush the tubing set with normal saline and upon inspection of the tubing noticed a bulge in the silicone segment.The nurse then discontinued use if this tubing set and replaced it.
 
Manufacturer Narrative
The device history record for set model 2420-0007.Lot 19125587 shows the set was manufactured on 04dec2019 with a total of (b)(4) units.There were no quality notifications issued during the production build of this component.
 
Event Description
It was reported from the outpatient infusion clinic, by the nurse that the pump alarmed "distal occlusion".The nurse paused the pump, readjusted the stop cock, checked tubing, and attempted to flush the tubing with a normal saline syringe.When flushing there was slight resistance.When checking the tubing the again, the nurse noticed the top blue part of the tubing just outside the chamber was raised.The tubing set was clamped and chamber door was opened, and a swollen area on the tubing was found.The iv tubing was removed and replaced.No adverse reaction to patient related to this event.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "alaris pump alarmed and stated distal occlusion.Nurse paused pump, readjusted the stop cock, checked tubing, and attempted to flush the line with ns syringe.When flushing there was slight resistance.When checking the line again, nursed noticed the top blue part of the tubing just outside the chamber was raised.The line was clamped and chamber door was opened.A swollen area on the tubing was found.The iv tubing was removed and replaced.".
 
Manufacturer Narrative
Cont¿d d.11: 250ml icu medical bag, lot number 08-130-jt, exp: 1aug2021, 0.9% sodium chloride injection and 4-way stopcock.The customer's report of a tubing set silicone segment bulge was confirmed.The silicone segment area, directly underneath the upper fitment, was misshapen and was of a different appearance than the rest of the silicone segment.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.No functional testing was performed due to visual observation the cause for this failure mode determined that the ballooning is caused by excess pressure within the silicone segment.The root cause for the source of the excessive pressure is unknown.
 
Event Description
It was reported from the outpatient infusion clinic, by the nurse that the pump alarmed "distal occlusion".The nurse paused the pump, readjusted the stop cock, checked tubing, and attempted to flush the tubing with a normal saline syringe.When flushing there was slight resistance.When checking the tubing the again, the nurse noticed the top blue part of the tubing just outside the chamber was raised.The tubing set was clamped and chamber door was opened, and a swollen area on the tubing was found.The iv tubing was removed and replaced.No adverse reaction to patient related to this event.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "alaris pump alarmed and stated distal occlusion.Nurse paused pump, readjusted the stop cock, checked tubing, and attempted to flush the line with ns syringe.When flushing there was slight resistance.When checking the line again, nursed noticed the top blue part of the tubing just outside the chamber was raised.The line was clamped and chamber door was opened.A swollen area on the tubing was found.The iv tubing was removed and replaced.".
 
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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 Key10091881
MDR Text Key192230746
Report Number9616066-2020-01666
Device Sequence Number1
Product Code FPA
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,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/04/2022
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number19125587
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8015, 8100, TD UNKNOWN.; SEE H.10; THERAPY DATE (B)(6) 2020; 8015, 8100, TD UNKNOWN.
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