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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION,INTRAVASCULAR Back to Search Results
Model Number PRI TUBING
Device Problem Backflow (1064)
Patient Problem Missed Dose (2561)
Event Date 02/09/2020
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer. The product was discarded and not returned for failure investigation. Although requested, information and race and ethnicity were not provided.
 
Event Description
It was reported that an unspecified 100ml antibiotic secondary infusion (yellow in color) back flowed into the primary bag of 500ml 0. 9% sodium chloride (clear in color). The customer provided a photo of the involved products where in the primary bag of sodium chloride turned into yellowish in color. The secondary bag was empty. The patient consequently did not receive the medication dose as the clinician was unsure how much volume was actually been administered. The event occurred in pediatric medicine unit. There was no serious injury but there was a delay in infusion therapy. The physician was notified and subsequent readjustment of the medication schedule was done.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET,ADMINISTRATION,INTRAVASCULAR
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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9926086
MDR Text Key194125123
Report Number9616066-2020-01178
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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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