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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PRESSURE SENSING MODULE SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION ALARIS PRESSURE SENSING MODULE SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 10014914
Device Problem Fluid/Blood Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 11/21/2019
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 (morphine) leaked between the connection of clave and tubing.It was reported that it delayed patient medication.
 
Manufacturer Narrative
The lot number originally provided is an invalid number; ((removal of lot # not captured or documented in (b)(4)).
 
Event Description
It was reported that (morphine) leaked between the connection of the clave and the tubing.It was reported that it delayed patient medication, and although requested; there has been no further impact to patient response or additional event information made available to date.
 
Event Description
It was reported that (morphine) leaked between the connection of the clave and the tubing.It was reported that it delayed patient medication, and although requested; there has been no further impact to patient response or additional event information made available to date.
 
Manufacturer Narrative
Additional information added to: d10.Correction; h.6.(patient code).The customer¿s report of leaking between the connection of clave and tubing was confirmed.Visual inspection after initial testing observed that the connection between the set¿s female luer and male luer side of the microclave connector was not fully tightened.Both of the components were inspected under a microscope with no damage observed and were found to be within specifications.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Functional testing was performed by using a lab bd 30ml syringe filled with blue-dyed water.The set was loaded into a lab syringe pump module device.A slow leak was observed at the connection between the female luer and male luer side of the microclave connector.No alarms or other issues were noted by the device.The root cause confirmed as the connection between the syringe psd microbore set¿s female luer and the microclave male luer side not being fully tightened.
 
Event Description
It was reported that (morphine) leaked between the connection of clave and tubing.It was reported that it delayed patient medication.
 
Manufacturer Narrative
Additional information added to: b3,d11,g3.
 
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Brand Name
ALARIS PRESSURE SENSING MODULE SET
Type of Device
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9532460
MDR Text Key191290843
Report Number9616066-2019-03773
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403233906
UDI-Public10885403233906
Combination Product (y/n)N
PMA/PMN Number
K811885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup,Followup
Report Date 12/09/2019
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 Model Number10014914
Device Catalogue Number10014914
Device Lot Number19087374
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received03/13/2020
03/16/2020
03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8110,8015,SYRINGE,TD (B)(6) 2019
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