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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 Problems Failure to Calibrate (2440); Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The customer reported problem was confirmed. The device was repaired, passed all require testing and specifications and released back to the customer. 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 trackwise complaint history review was completed, and it was confirmed that there were additional complaints received with similar sn (b)(4) for the same or related failure mode. The customer stated that there was no patient involvement.
 
Event Description
(b)(4). There is no allegation of patient involvement. (b)(4). The customer did not return the device for evaluation. A review of the device history record for sn (b)(4) was performed from 12/17/2018 to 3/2/2020 and confirmed that this device was previously returned for servicing unrelated to the customer reported issue. There were no production failure/s which correlate/s to the customer reported issue.
 
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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
priya prabhakaran santha
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11264591
MDR Text Key240849034
Report Number2016493-2021-22348
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2021
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? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2018
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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