• 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 2420-0007
Device Problem Stretched (1601)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer. The customer complaint could not be confirmed because the product was not sequestered for failure investigation. The root cause of this failure was not identified. No additional patient information will be provided.
 
Event Description
Customer advocacy received a copy of the customer's medwatch report from the fda which reports: "pump alarm sounded, and nurse checked pump to find that the tubing in the pump had a large diameter swelling in the soft portion of the tubing at least 5 times the diameter of the normal tubing size. " an incomplete date of event of (b)(6) 2019 was provided.
 
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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9440817
MDR Text Key196243324
Report Number9616066-2019-03613
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 health professional,other,use
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2019
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 Number19105452
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-