Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2020
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.
 
Event Description
The reported feedback suggests that the spike is broken.From the reported information there are no indications of serious injury to the patient or user as a result of this incident.
 
Event Description
The reported feedback suggests that the spike is broken.
 
Manufacturer Narrative
The customer's report that the spike was broken was confirmed.A visual inspection confirmed the customer¿s report as the tip of the spike of the 2420-0007 had snapped and was lodged within the spike port adaptor of the 82113eh.The root cause of the customer' report could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALARIS® PUMP MODULE ADMINISTRATION SET
Type of Device
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9831950
MDR Text Key192147101
Report Number9616066-2020-00809
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number19086345
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-