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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 Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The customer¿s concerns for an unknown error was confirmed during testing. Testing performed on the returned etco2 module in the ¿as received¿ condition showed that when the device is attached to a test pcu, the device immediately alarms for a ¿system error¿ code 9-100-1318. Tracker (b)(4) was opened to investigate the error code 9-100-1318. The error is the result of an invalid model number. The source etco2 module event log confirmed the device had a model and serial number of ¿0¿ (zero). The model number and serial numbers were corrected using flash tools. Further testing confirmed the issue could also be resolved using asm test software. Attempts were made to replicate a ¿0¿ model and serial number; however, testing failed to replicate the anomaly by entering ¿0¿ in the model field. It is believed the device encountered software corruption. As a precaution the service will replace the logic board and calibration before returning the device to the customer. Based on the logs, there was no patient involvement. A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue. A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode. The customer stated that there was patient involvement.
 
Event Description
It was reported that there were four etco2 devices that malfunctioned. It is unknown which of the four devices malfunctioned during patient use, therefore, the customer is sending in all four devices for investigational purposes. The etco2 device alarmed for "error-unknown".
 
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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
sujitha jayaraman
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11093363
MDR Text Key224298594
Report Number2016493-2020-84711
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,other
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/18/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2019
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 Manufactured01/13/2017
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
CAD_ETCO2_DISP,8015,CAD_PCA_TUBE,8120.
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