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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 2420-0500
Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889)
Patient Problem No Information (3190)
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 tubing set inside the lvp pump was ballooning instead of infusing.
 
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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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9716640
MDR Text Key191694848
Report Number9616066-2020-00480
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number19125579
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2019
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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