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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SPO2; PUMP, INFUSION
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CAREFUSION SD ALARIS SPO2; PUMP, INFUSION Back to Search Results
Model Number 8210
Device Problem Contamination (1120)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
It was reported that there were issues due to fluid ingress for these 8210 devices."while they were working they began to put aside modules with corrosion and lamination issues with the keypads." customer confirmed no patient involvement.
 
Manufacturer Narrative
Correction: please disregard file.After further review, the file is now deemed as non-reportable malfunction.
 
Event Description
It was reported, that there were corrosion and lamination issues, noted on their 8210 (oximetry) devices."while they were working, they began to put aside modules with corrosion and lamination issues with the keypads".Customer confirmed, no patient involvement.
 
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Brand Name
ALARIS SPO2
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key11228617
MDR Text Key228622702
Report Number2016493-2021-17629
Device Sequence Number1
Product Code DQA
UDI-Device Identifier10885403821011
UDI-Public10885403821011
Combination Product (y/n)N
PMA/PMN Number
K022677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8210
Device Catalogue Number8210
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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