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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD 8300 ALARIS ETCO2 MODULE PUMP, INFUSION

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CAREFUSION SD 8300 ALARIS ETCO2 MODULE PUMP, INFUSION Back to Search Results
Model Number 8300
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The reported issue that an etco2 module had alarmed for channel error that could not be cleared could not be confirmed; no product or device logs were returned for investigation. The file was opened to document the issue that was reported. No further investigation of this event is possible at this time. No device history or qn search was performed since no source device serial number was reported by the customer. The system was being used for treatment. The file may be closed based on the above facts. A dhr (device history record) review cannot be completed as the serial number was not obtained upon receipt of the complaint. Additionally, a historical review of complaints in trackwise cannot be conducted.
 
Event Description
It was reported that a etco2 monitor alarmed for "channel error" during an unspecified pca infusion. The rn attempted to trouble-shoot however the devices would not resolve the error; the user shut the pca module down and restarted the infusion but the etco2 module remained " with a red alarm" with no option to turn the module off while the pca module continued to work without an issue. Although requested, no further details were provided by the customer for this event.
 
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Brand Name8300 ALARIS ETCO2 MODULE
Type of DevicePUMP, 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
tejas deshmuk
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11095865
MDR Text Key224404976
Report Number2016493-2020-85879
Device Sequence Number1
Product Code CCK
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,health
Reporter Occupation
Type of Report Initial
Report Date 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8300
Device Catalogue Number8300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/30/2020 Patient Sequence Number: 1
Treatment
8120,8015,CAD_ETCO2_DISP,CAD_PCA_TUBE,
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