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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number SEC TUBING
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem Underdose (2542)
Event Type  malfunction  
Manufacturer Narrative
No product returned. Because no product was returned or expected to be returned, no failure investigation could be performed. The root cause of the customer's experience was not identified although requested, no patient details provided.
 
Event Description
It was reported that there was an under infusion of an antibiotic during secondary tubing use. It was noted that "the slide clamp kinks off the tubing sometimes and all of the antibiotic will not infuse. " although requested, no patient information was provided.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9578388
MDR Text Key191583026
Report Number9616066-2020-00132
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSEC TUBING
Device Catalogue NumberSEC TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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