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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® PRIMARY ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS® PRIMARY ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0500
Device Problem Reflux within Device (1522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2019
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the affected product be received for evaluation.Although requested, patient demographics not provided.
 
Event Description
The customer reported that a secondary infusion of zosyn (3.375 grams in 50ml) was noted to be back infusing into primary bag of 0.9% sodium chloride.The pump was programmed to infuse at 200ml/hr.There was no harm.
 
Event Description
The customer reported that a secondary infusion of zosyn (3.375 grams in 50ml) was noted to be back infusing into primary bag of 0.9% sodium chloride.The pump was programmed to infuse at 200ml/hr.There was no harm.
 
Manufacturer Narrative
The customer¿s report of backflow was not confirmed.No anomalies were observed during visual inspection.The check valve was visually inspected under magnification and was found to be assembled in the set correctly with the silicone membrane centered.Functional testing was performed; no backflow into the primary bag was observed.The check valve component was returned to the supplier for additional analysis.Testing indicated a pass result.Disassembly of the check valve resulted in normal findings.There were no particulates noted on the diaphragm membrane, no solvent in the check valve component, and no damages to the interior of the check valve or the diaphragm.The root cause of the reported backflow was not identified.
 
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Brand Name
ALARIS® PRIMARY ADMINISTRATION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8291236
MDR Text Key134597948
Report Number9616066-2019-00290
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 health professional
Type of Report Initial,Followup
Report Date 01/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
72213N, 8015,8100; SEC TUBING, THERAPY DATE (B)(6) 2019
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