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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 2420-0007
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed.
 
Event Description
It was reported from the day surgery unit that just prior to use, the newly primed primary tubing set leaked "normal iv fluid". There was a "minimal delay" caused because a new tubing set had to be prepared. It was observed that the packaging had a little cut on it which the customer thinks is how the tubing set became cut also. There was no patient involvement as this happened prior to use.
 
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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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10110451
MDR Text Key193652062
Report Number9616066-2020-01863
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number20033350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2020
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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