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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 Break (1069); Crack (1135); No Device Output (1435); Mechanics Altered (2984); Naturally Worn (2988)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This reported event and any subsequent repairs have been investigated through the normal service repair process.Failure data and parts used information, was reviewed for the sap file and track wise file, and found to be relevant to the service repair.A review of the source device service history record was performed beginning from the date of manufacture to the present date.Service returns were for unrelated issues.The database showed no quality notifications were opened for the source device.A review of the device history record in sap for sn (b)(4) was performed which confirmed that this device was not involved in a production failure and product was returned for the 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.Capa reference: (b)(4).The customer stated that there was no patient involvement.
 
Event Description
(b)(4).This unit was rur in previous notification (b)(4) due to unresponsive customer.Device will be estimated for fail leak down test and need to replace oridion pcb.Crack front case and after market rear case.Submitted for customer approval for major repair.(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
naveen balaji kumar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10545164
MDR Text Key221311014
Report Number2016493-2020-05794
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
Remedial Action Recall
Type of Report Initial
Report Date 01/09/2018
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 Received09/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2008
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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