• 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, INFUSION

  • 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, INFUSION Back to Search Results
Model Number 11607704
Device Problems Break (1069); Separation Failure (2547)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
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. Patient information was requested, but not provided.
 
Event Description
It was reported that the patient was hooked up to normal saline to another manufacture port. The tubing was broken at the y-site and the blood had started to flow out of the remaining tubing that was still attached to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INFUSION
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
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9410031
MDR Text Key190013768
Report Number9616066-2019-03533
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403228001
UDI-Public10885403228001
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2022
Device Model Number11607704
Device Catalogue Number11607704
Device Lot Number19087383
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-