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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 the etco2 modules failed calibration due to a board failure, receiving error code 570. 6200 could not be confirmed; no product or device logs were returned for investigation. The file was opened to document the issue that was reported. 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 issue was reported to have occurred during the pm process and was not involved with any patient incident. The etco2 module is used for patient monitoring during 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. The customer stated that there was patient involvement.
 
Event Description
It was reported that the etco2 modules failed calibration due to a board failure, receiving error code 570. 6200. The customer confirmed that there was no patient involvement as error was found during preventive maintenance. The facility recently acquired the modules in (b)(6) 2019.
 
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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
prabhu somu
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11093303
MDR Text Key225103726
Report Number2016493-2020-83044
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
PMA/PMN Number
K031741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 10/31/2019
1 Device was Involved in the Event
0 Patients were 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

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