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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 2426-0007
Device Problem Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2020
Event Type  malfunction  
Manufacturer Narrative
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. Patient's demographics requested, but was not provided.
 
Event Description
It was reported that during an infusion of normal saline (600ml / 75c/hr. ), the pump module while connected to the patient alarmed air-in-line. When the nurse opened the door, she noticed the line had a large bulge below the upper fitment. There was no patient impact.
 
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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 Key10155574
MDR Text Key195249682
Report Number9616066-2020-01882
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
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 Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot Number20026609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2020
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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