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, ADMIN, 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, ADMIN, INTRAVASCULAR. Back to Search Results
Model Number 2420-0007
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2020
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
 
Event Description
It was reported from neuro icu that the tubing set appeared to develop an aneurysm in the tubing which caused the pump to alarm and the tubing to be replaced.The customer indicated that they do not think the tubing is faulty, but that a module was faulty or nurses were leaving the clamp closed as potential causes for the issue.There was no reported harm to the patient.
 
Manufacturer Narrative
Customer occupation updated.Title added to g3 other field.Health professional removed from categories and other added.E3 occupation changed to n/a.
 
Event Description
It was reported from neuro icu that the tubing set appeared to develop an aneurysm in the tubing which caused the pump to alarm and the tubing to be replaced.The customer indicated that they do not think the tubing is faulty, but that a module was faulty or nurses were leaving the clamp closed as potential causes for the issue.There was no reported harm to the patient.
 
Manufacturer Narrative
The customer report of tubing set appeared to develop an aneurysm in the tubing which caused the pump to alarm could not be confirmed due to the product was not returned for failure investigation.Device history record for model 2420-0007 lot 20026898 shows that the set was manufactured on 24 february 2020 with a total of 23,043 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.The root cause of this failure was not identified as no product was returned.
 
Event Description
It was reported from neuro icu that the tubing set appeared to develop an aneurysm in the tubing which caused the pump to alarm and the tubing to be replaced.The customer indicated that they do not think the tubing is faulty, but that a module was faulty or nurses were leaving the clamp closed as potential causes for the issue.There was no reported harm to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, ADMIN, INTRAVASCULAR.
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10035788
MDR Text Key190313275
Report Number9616066-2020-01574
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public7613203021012
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/24/2023
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number20026898
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100,8015, THERAPY DATE (B)(6) 2020.; 8100,8015, THERAPY DATE 01/01/2020
-
-