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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION
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CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION Back to Search Results
Model Number 8015
Device Problems Thermal Decomposition of Device (1071); Failure to Read Input Signal (1581)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2023
Event Type  malfunction  
Event Description
It was reported that the device would not power on.There was no patient involvement.
 
Manufacturer Narrative
A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.
 
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Brand Name
ALARIS SYSTEM
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
brett wilko
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key16806796
MDR Text Key313917175
Report Number2016493-2023-153658
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403801549
UDI-Public(01)10885403801549
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8015
Device Catalogue Number8015 ALARIS PCU 1.5 MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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