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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS SYRINGE MODULE; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS SYRINGE MODULE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10014914
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem Underdose (2542)
Event Date 02/13/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: (2) used ganged stopcocks (unspecified manufacturer) and (1) used non-bd set; 10ml covidien syringe; td (b)(6) 2020.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Although requested, no patient information provided.
 
Event Description
It was reported that the there was a maxzero crack and leak.The event occurred in the cvicu.Per the reporter, "blood back up in white cvl lumen- into train." a crack was found which resulted in a precedex leak.The patient did not receive full dose of precedex and milrinone as a result.
 
Manufacturer Narrative
Continued from d.11:(2) used ganged stopcocks (unspecified manufacturer) ;used non-bd set; td (b)(6) 2020.Additional info: d.11.
 
Event Description
It was reported that the there was a maxzero crack and leak.The event occurred in the cvicu.Per the reporter, "blood back up in white cvl lumen- into train." a crack was found which resulted in a precedex leak.The patient did not receive full dose of precedex and milrinone as a result.
 
Manufacturer Narrative
The customer¿s report that the there was a maxzero crack and leaked causing blood to back up was confirmed.Visual inspection observed a lateral crack in the female luer wall of the set located at the top end of the female luer opposite of the luer gate.Residual blood was also observed within the 2 ganged stopcocks.Functional testing showed small droplets were leaking at the connection between model mz1000-07 and model 10014914.The root cause of the female luer crack was identified to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks and the pvc materials used in the new female luer.A device history record for model mz1000-07 with lot number 19107081 was performed.The search showed that a total of 76,803 units were built in 1 lot on 26oct2019.The search showed that there were no quality notifications for the failure mode reported by the customer.A device history record for model 10014914 with lot number 19087377 was performed.The search showed that a total of 12,003 units were built in 1 lot on (b)(6) 2019.The search showed that there were no quality notifications for the failure mode reported by the customer.
 
Event Description
It was reported that the there was a maxzero crack and leak.The event occurred in the cvicu.Per the reporter; "blood back up in white cvl lumen- into train".A crack was found which resulted in a precedex leak.The patient did not receive the full dose of precedex and milrinone as a result.Although requested, there has been no further impact to patient response or additional event information made available to date.
 
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Brand Name
ALARIS SYRINGE MODULE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9852963
MDR Text Key192186466
Report Number9616066-2020-00824
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403230196
UDI-Public10885403230196
Combination Product (y/n)N
PMA/PMN Number
K811885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/20/2022
Device Model Number10014914
Device Catalogue Number10014914
Device Lot Number19087377
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(2)8110,SYR TUBING, TD (B)(6) 2020; 10014914,30910, TD (B)(6) 2020; MZ1000-07,10ML COVIDIEN SYRINGE, TD (B)(6) 2020
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