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 2200-0500
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event or Problem Description
During a site visit it was reported that the safety clamp did not engage when it was removed from the device.The clinician stated,"the ¿safety clamp did not activate¿ and the roller clamp was not engaged.Ns [normal saline] flowed out of tubing." the clinician was exposed to the ns inside the tubing set.This event occurred on the outpatient oncology unit.The tubing was not connected to the patient.There was no patient harm.The pump and the tubing were not sequestered.Tubing ref#2200-0500.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALARIS® PUMP MODULE ADMINISTRATION SET
Common Device Name
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9868364
Report Number9616066-2020-01034
Device Sequence Number3040780
Product Code FPA
UDI-Device Identifier07613203012638
UDI-Public7613203012638
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K931173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number2200-0500
Device Catalogue Number2200-0500
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-