• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION,INTRAVASCULAR Back to Search Results
Model Number 2426-0500
Device Problems Backflow (1064); Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2020
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 is an adult.
 
Event Description
It was reported from the or that the iv tubing set ballooned/bulged during a saline flush which caused the tubing to backflow and stopped working, it was replaced. There was no patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10176796
MDR Text Key196795668
Report Number9616066-2020-01893
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
Type of Report Initial,Followup,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0500
Device Catalogue Number2426-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-