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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 Computer Software Problem (1112); Contamination (1120); Corroded (1131); Mechanics Altered (2984); 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, retested and returned 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).
 
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Brand Name
8300 ALARIS ETCO2 MODULE
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
jeevan mandal
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11184718
MDR Text Key231584737
Report Number2016493-2021-10912
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2011
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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