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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS SECONDARY SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS SECONDARY SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MS3500
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
It was reported that at the completion of a secondary infusion, the iv tubing set leaked from the secondary junction while connected to the secondary part of the maintenance line.The connection was tight and no crack was noted.There was no patient impact.
 
Event Description
It was reported that at the completion of ceftolozane/tazobactam1,000mg in 100ml ns secondary infusion, a leak was observed at the connection between secondary and primary sets.Potassium chloride 20meq was infusing through the primary set.It was noted that the connection between two sets was tight and no crack was seen.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
 
Event Description
It was reported that at the completion of a secondary infusion, the iv tubing set leaked from the secondary junction while connected to the secondary part of the maintenance line.The connection was tight and no crack was noted.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
 
Manufacturer Narrative
Additional information; section; b.5.(patient/event information clarified/detailed) the customer¿s report that the set leaked at the connection between the primary and secondary set was not confirmed.The sets in their as received configuration were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted no damage or any anomalies.Functional testing resulted in fluid flowing freely through both the primary and secondary set with no signs of leaking at the connection or anywhere else throughout the sets.The sets in their as received configuration were loaded into a lab pump module for an infusion test.The primary and secondary infusions were programmed and both primary and secondary infusions completed with no leaks at the connection or anywhere else throughout the sets.Pressure testing resulted in no air entering the line anywhere on the set while the tubing was manipulated at each engagement.The smartsite female and secondary set¿s male luer ports were measured and were within iso standards.The root cause of the customer¿s report could not be identified.
 
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Brand Name
ALARIS SECONDARY SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9525771
MDR Text Key193958246
Report Number9616066-2019-03746
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403222603
UDI-Public10885403222603
Combination Product (y/n)N
PMA/PMN Number
K051499
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 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/14/2022
Device Model NumberMS3500
Device Catalogue NumberMS3500
Device Lot Number19085848
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received04/16/2020
05/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
100 ML BAXTER BAG,1000 ML BAXTER BAG, TD (B)(6) 2019; 8100, 8015
Patient Age14 YR
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