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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD 8300 ALARIS ETCO2; PUMP, INFUSION
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CAREFUSION SD 8300 ALARIS ETCO2; PUMP, INFUSION Back to Search Results
Model Number 8300 ALARIS ETCO2 MODULE
Device Problem Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  malfunction  
Manufacturer Narrative
The information provided was obtained from a retrospective review of servicing data; therefore, no other information is obtainable at this time.There was no reported patient involvement.
 
Event Description
It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no reported patient involvement.
 
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Brand Name
8300 ALARIS ETCO2
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
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 Key14099691
MDR Text Key297433933
Report Number2016493-2022-858962
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10885403830013
UDI-Public10885403830013
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8300 ALARIS ETCO2 MODULE
Device Catalogue Number8300 ALARIS ETCO2 MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2020
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2018
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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